Implantable electrical leads and associated delivery systems

ABSTRACT

Disclosed is a delivery system for a component, for example, a splitting lead. A splitting lead can have a proximal portion to engage a controller and a distal portion to split apart into sub-portions that travel in multiple directions during implantation into a patient. The delivery system can include a handle and a component advancer to advance and removably engage a portion of the component. The component advancer can be coupled to the handle and advance the component into the patient by applying a force to the portion in response to actuation of the handle by the operator. Also, the delivery system can include an insertion tip with first and second ramps to facilitate advancement of first and second sub-portions into the patient in first and second directions. The leads may have various electrode configurations including, for example, wrapped or embedded electrodes, helical or elliptical coils, thin metallic plates, etc.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of and claims priority toU.S. patent application Ser. No. 16/888,462, filed May 29, 2020. Thisapplication also claims priority to U.S. Provisional Patent ApplicationNo. 63/049,561, filed Jul. 8, 2020. The disclosures of each areincorporated herein by reference in their entirety.

DESCRIPTION OF THE RELATED ART

Electrical leads can be implanted in patients for a variety of medicalpurposes. In one particular application, leads can be implanted to workin conjunction with a cardiac pacemaker or cardiac defibrillator.Pacemakers and cardiac defibrillators are medical devices that helpcontrol abnormal heart rhythms. A pacemaker uses electrical pulses toprompt the heart to beat at a normal rate. The pacemaker may speed up aslow heart rhythm, control a fast heart rhythm, and/or coordinate thechambers of the heart. Defibrillators can be provided in patients whoare expected to, or have a history of, severe cardiac problems that mayrequire electrical therapies up to and including the ceasing ofventricular fibrillation, otherwise known as cardiac arrest.Defibrillators may include leads that are physically inserted into theheart, including into the heart tissue (e.g., with screw-in lead tips)for the direct delivery of electrical current to the heart muscle.

The portions of pacemaker or ICD systems generally comprise three maincomponents: a pulse generator, one or more wires called leads, andelectrode(s) found on each lead. The pulse generator produces theelectrical signals that help regulate the heartbeat. Most pulsegenerators also have the capability to receive and respond to signalsthat come from the heart. Leads are generally flexible wires thatconduct electrical signals from the pulse generator toward the heart.One end of the lead is attached to the pulse generator and the other endof the lead, containing the electrode(s) is positioned on, in or nearthe heart.

When the exemplary embodiments discussed herein refer to cardiac pacing,it is contemplated that the embodiments and technologies disclosed mayalso be used in conjunction with defibrillation/ICD applications.Similarly, when exemplary embodiments discussed herein refer todefibrillation/ICD applications, it is contemplated that the embodimentsand technologies disclosed may also be used in conjunction with cardiacpacing applications.

SUMMARY

Systems, methods, and devices to facilitate insertion of certain leadswith electrode(s) into patients for a variety of medical purposes aredescribed. In some implementations, an electrical lead for implantationin a patient can include a distal portion with electrodes that areconfigured to generate therapeutic energy for biological tissue of thepatient. The electrical lead can have a proximal portion coupled to thedistal portion and configured to engage a controller configured to causethe electrodes to generate the therapeutic energy. At least a portion ofthe distal portion of the lead can have two parallel planar surfacesthat include the electrodes.

In some implementations, the electrodes can be thin metallic plates. Inother implementations, the electrical lead can include an electricallyinsulating mask over a portion of the coil(s) on one of the parallelplanar surfaces.

In some implementations, at least one electrode can be partiallyembedded in the portion of the distal portion of the lead, with thepartially embedded electrode having an embedded portion and an exposedportion. In some implementations, the partially embedded electrode canbe a circular helical coil or an elliptical helical coil.

Further disclosed is a method that can include placing a lead comprisingboth defibrillation and cardiac pacing electrodes at an extravascularlocation within a patient. The extravascular location can be in a regionof a cardiac notch, or on or near the inner surface of an intercostalmuscle. In some implementations, the placing can include inserting thelead through an intercostal space associated with the cardiac notch of apatient.

Also disclosed is a computer program product that can perform operationsincluding receiving sensor data; determining, based at least on thesensor data, an initial set of electrodes on a defibrillation leadincluding more than two defibrillation electrodes, from which to delivera defibrillation pulse; delivering the defibrillation pulse with theinitial set of electrodes; receiving post-delivery sensor data;determining, based at least on the post-delivery sensor data whether thedefibrillation pulse successfully defibrillated the patient; and, ifnecessary, determining an updated set of electrodes from which todeliver a subsequent defibrillation pulse.

Further disclosed is an electrical lead for implantation in a patientthat can include a distal portion with electrodes that are configured togenerate therapeutic energy for biological tissue of the patient. Theelectrical lead can have a proximal portion coupled to the distalportion and configured to engage a controller configured to cause theelectrodes to generate the therapeutic energy. The distal portion cansplit apart into sub-portions that travel in multiple directions duringimplantation into the patient. The distal portion can split apart intotwo sub-portions of equal length. The electrodes can be wrapped aroundthe sub-portions that travel in multiple directions during implantationand can include defibrillation electrodes and/or cardiac pacingelectrodes.

In some implementations, the electrode(s) can be wrapped around aproximal part of the distal portion of the lead, which does not travelin a different direction during implantation. In some implementations, apacing electrode extends between the sub-portions that travel inmultiple directions during implantation.

In other implementations, electrodes can be partially embedded in thesub-portions that travel in multiple directions during implantation, andthe partially embedded electrodes can have an embedded portion and anexposed portion. In some implementations, the exposed portions can beoffset in order to avoid interference when the distal portion of theelectrical lead is folded before it splits apart into sub-portions thattravel in multiple directions during implantation. In some embodiments,the electrical lead can have concavities on the sub-portions such thatexposed portions of the offset electrodes fit within the concavitieswhen the electrical lead is folded.

In some implementations, the electrical lead can have suture holes in aproximal part of the distal portion of the lead, which does not travelin a different direction during implantation. In some implementations,the electrical lead can have grooves or notches on a proximal part ofthe distal portion of the lead, which does not travel in a differentdirection during implantation.

Also disclosed is a delivery system for a component that can be, forexample, a splitting lead. The splitting lead can have a proximalportion configured to engage a controller and a distal portionconfigured to split apart into sub-portions that travel in multipledirections during implantation into a patient. The delivery system caninclude a handle configured to be actuated by an operator and acomponent advancer configured to advance the component into the patient.The component advancer can be configured to removably engage a portionof the component and may be coupled to the handle and configured toadvance the component into the patient by applying a force to theportion of the component in response to actuation of the handle by theoperator. The delivery system can also include an insertion tip having afirst ramp configured to facilitate advancement of a first sub-portioninto the patient in a first direction, and a second ramp configured tofacilitate advancement of a second sub-portion into the patient in asecond direction. In some implementations, the first direction can beopposite the second direction. In other implementations, the deliverysystem can include a third ramp configured to facilitate advancement ofa third sub-portion into the patient in a third direction. The firstramp can include a gap configured to facilitate removal of the deliverysystem after implantation of the splitting lead.

In some implementations, the insertion tip can include atissue-separating component. The tissue-separating component can bewedge-shaped or have a blunted distal end. In some implementations, thetissue-separating component can include a gap configured to facilitateremoval of the delivery system after implantation of the splitting lead.The insertion tip may further include a movable cover configured tocover the gap. In some implementations, the delivery system can includethe splitting lead, where a distal end of the splitting lead includes agap-filling component configured to fill the gap of thetissue-separating component when the splitting lead is loaded into thedelivery system.

Further disclosed is a method that can include inserting a lead deliverysystem into a patient; operating the lead delivery system to advance alead so that a distal portion of the lead splits apart and travels inmultiple directions within the patient.

In some implementations, the distal portion of the lead splits apartinto two portions that travel in opposite directions parallel to asternum of the patient. In other implementations, the distal portion ofthe lead splits apart into two portions that travel in directionsapproximately 100° apart and under a sternum of the patient. In someimplementations, the distal portion splits apart into three portionsthat travel in directions approximately 90° apart and parallel orperpendicular to a sternum of the patient.

Implementations of the current subject matter can include, but are notlimited to, methods consistent with the descriptions provided herein aswell as articles that comprise a tangibly embodied machine-readablemedium operable to cause one or more machines (e.g., computers, etc.) toresult in operations implementing one or more of the described features.Similarly, computer systems are also contemplated that may include oneor more processors and one or more memories coupled to the one or moreprocessors. A memory, which can include a computer-readable storagemedium, may include, encode, store, or the like, one or more programsthat cause one or more processors to perform one or more of theoperations described herein. Computer implemented methods consistentwith one or more implementations of the current subject matter can beimplemented by one or more data processors residing in a singlecomputing system or across multiple computing systems. Such multiplecomputing systems can be connected and can exchange data and/or commandsor other instructions or the like via one or more connections, includingbut not limited to a connection over a network (e.g., the internet, awireless wide area network, a local area network, a wide area network, awired network, or the like), via a direct connection between one or moreof the multiple computing systems, etc.

The details of one or more variations of the subject matter describedherein are set forth in the accompanying drawings and the descriptionbelow. Other features and advantages of the subject matter describedherein will be apparent from the description and drawings, and from theclaims. While certain features of the currently disclosed subject matterare described for illustrative purposes in relation to particularimplementations, it should be readily understood that such features arenot intended to be limiting. The claims that follow this disclosure areintended to define the scope of the protected subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, show certain aspects of the subject matterdisclosed herein and, together with the description, help explain someof the principles associated with the disclosed implementations. In thedrawings,

FIG. 1 is a diagram illustrating exemplary placements of elements of acardiac pacing system, in accordance with certain aspects of the presentdisclosure;

FIG. 2A is an illustration of an exemplary lead delivery systemfacilitating delivery of a cardiac pacing lead in the region of acardiac notch, in accordance with certain aspects of the presentdisclosure;

FIG. 2B illustrates a distal end of an exemplary lead delivery systemhaving dropped into an intercostal space in the region of the cardiacnotch, in accordance with certain aspects of the present disclosure;

FIG. 2C illustrates an electrical lead exiting the exemplary deliverysystem with two electrodes positioned on a side of the lead facing theheart, in accordance with certain aspects of the present disclosure;

FIG. 3 illustrates an exemplary delivery system, in accordance withcertain aspects of the disclosure;

FIG. 4 illustrates an example of first and second insertion tips of thedelivery system with blunt edges, in accordance with certain aspects ofthe disclosure;

FIG. 5 illustrates an exemplary channel at least partially complimentaryto a shape of the component and configured to guide the component intothe patient, in accordance with certain aspects of the disclosure;

FIG. 6 illustrates a first insertion tip being longer than a secondinsertion tip, in accordance with certain aspects of the disclosure;

FIG. 7 illustrates an example of a ramped portion of an insertion tip,in accordance with certain aspects of the disclosure;

FIG. 8 illustrates an example of insertion tips with open side walls, inaccordance with certain aspects of the disclosure;

FIG. 9A illustrates one possible example of a delivery system having aunitary insertion tip, in accordance with certain aspects of thedisclosure;

FIG. 9B illustrates one possible example of a unitary insertion tip, inaccordance with certain aspects of the disclosure;

FIG. 9C illustrates an alternative insertion tip design having a wedgeshape, in accordance with certain aspects of the disclosure;

FIG. 9D illustrates certain features applicable to a unitary insertiontip design, in accordance with certain aspects of the disclosure;

FIG. 10 illustrates an exemplary lock for a delivery system, in a lockedposition, in accordance with certain aspects of the disclosure;

FIG. 11 illustrates the lock in an unlocked position, in accordance withcertain aspects of the disclosure;

FIG. 12A illustrates an example rack and pinion system that may beincluded in a component advancer of the delivery system, in accordancewith certain aspects of the disclosure;

FIG. 12B illustrates an example clamp system that may be included in acomponent advancer of the delivery system, in accordance with certainaspects of the disclosure;

FIG. 13 illustrates a view of an exemplary implementation of a componentadvancer including a pusher tube coupled with the handle of a deliverysystem, in accordance with certain aspects of the disclosure;

FIG. 14 illustrates another view of the exemplary implementation of thecomponent advancer including the pusher tube coupled with the handle ofthe delivery system, in accordance with certain aspects of thedisclosure;

FIG. 15 illustrates the exemplary insertion tips in an open position, inaccordance with certain aspects of the disclosure;

FIG. 16 illustrates an example implementation of an electrical lead, inaccordance with certain aspects of the disclosure;

FIG. 17 illustrates another example implementation of an electricallead, in accordance with certain aspects of the disclosure;

FIG. 18 illustrates a distal portion of an exemplary electrical leadbent in a predetermined direction, in accordance with certain aspects ofthe disclosure;

FIG. 19 illustrates the distal portion bending in the predetermineddirection when the lead exits the delivery system, in accordance withcertain aspects of the disclosure;

FIG. 20 illustrates an exemplary implementation of the distal portion ofa lead, in accordance with certain aspects of the disclosure;

FIG. 21 illustrates another exemplary implementation of the distalportion of a lead, in accordance with certain aspects of the disclosure;

FIG. 22 illustrates an example of an electrode, in accordance withcertain aspects of the disclosure;

FIG. 23 illustrates a cross section of the example electrode, inaccordance with certain aspects of the disclosure;

FIG. 24 is a diagram illustrating a simplified perspective view of anexemplary directional lead with panel electrodes in accordance withcertain aspects of the present disclosure;

FIG. 25A is a diagram illustrating a simplified perspective view of anexemplary directional lead with elliptical panel electrodes inaccordance with certain aspects of the present disclosure;

FIG. 25B is a diagram illustrating a simplified perspective view of anexemplary directional lead with elliptical coil electrodes in accordancewith certain aspects of the present disclosure;

FIG. 26 is a diagram illustrating a simplified perspective view of anexemplary directional lead with embedded directional electrodes inaccordance with certain aspects of the present disclosure;

FIG. 27 is a diagram illustrating a simplified perspective view of anexemplary directional lead with masked circumferential defibrillationcoil electrodes in accordance with certain aspects of the presentdisclosure;

FIG. 28 is a diagram illustrating a simplified junction box inaccordance with certain aspects of the present disclosure;

FIG. 29 is a flow chart illustrating an exemplary process for performingdefibrillation in accordance with certain aspects of the presentdisclosure;

FIGS. 30A and 30B illustrate an exemplary splitting lead exiting adelivery system, in accordance with certain aspects of the presentdisclosure;

FIGS. 31A and 31B illustrate exemplary implantationlocations/orientations for exemplary splitting leads, in accordance withcertain aspects of the present disclosure;

FIG. 32 illustrates an exemplary splitting lead exiting an exemplarydelivery system, in accordance with certain aspects of the presentdisclosure;

FIG. 33 illustrates an exemplary splitting lead with wrapped electrodes,in accordance with certain aspects of the present disclosure;

FIG. 34 illustrates an exemplary splitting lead with a pacing electrodeextending between lead sub-portions, in accordance with certain aspectsof the present disclosure;

FIG. 35 illustrates a lead with exemplary suture holes and a pacingelectrode extending from the lead, in accordance with certain aspects ofthe present disclosure;

FIG. 36 illustrates an exemplary splitting lead with an embeddedcircular helical coil electrode, in accordance with certain aspects ofthe present disclosure;

FIG. 37 illustrates an exemplary splitting lead with an embeddedelliptical helical coil electrode, in accordance with certain aspects ofthe present disclosure;

FIG. 38 illustrates an exemplary splitting lead with multiple embeddedelectrodes, in accordance with certain aspects of the presentdisclosure;

FIG. 39 illustrates an exemplary splitting lead with multipleside-by-side embedded electrodes, in accordance with certain aspects ofthe present disclosure;

FIG. 40A illustrates an exemplary splitting lead with offset embeddedelectrodes, in accordance with certain aspects of the presentdisclosure;

FIG. 40B illustrates an exemplary splitting lead with offset embeddedelectrodes that fit into opposing concavities, in accordance withcertain aspects of the present disclosure;

FIG. 41A illustrates an exemplary delivery system deploying a component,in accordance with certain aspects of the present disclosure;

FIG. 41B illustrates the delivery system of FIG. 41A at a later stage ofdeployment, in accordance with certain aspects of the presentdisclosure;

FIG. 41C illustrates the delivery system of FIG. 41A at a yet laterstage of deployment, in accordance with certain aspects of the presentdisclosure;

FIG. 41D illustrates an exemplary gap-filling component of a splittinglead for use with a delivery system such as depicted in FIGS. 41A-C, inaccordance with certain aspects of the present disclosure;

FIG. 42 illustrates exemplary components of a delivery system configuredto load (or reload) a component (e.g., an electrical lead) into thedelivery system, in accordance with certain aspects of the disclosure;and,

FIG. 43 illustrates an example of an alignment block coupled to aproximal portion of an electrical lead, in accordance with certainaspects of the disclosure.

DETAILED DESCRIPTION

Implantable medical devices such as cardiac pacemakers or implantablecardioverter defibrillators (ICDs) may provide therapeutic electricalstimulation to the heart of a patient. The electrical stimulation may bedelivered in the form of electrical pulses or shocks for pacing,cardioversion or defibrillation. This electrical stimulation istypically delivered via electrodes on one or more implantable leads thatare positioned in, on or near the heart.

In one particular implementation discussed herein, a lead may beinserted in the region of the cardiac notch of a patient so that thedistal end of the lead is positioned within the mediastinum, adjacent tothe heart. For example, the distal end of the lead may be positioned inthe anterior mediastinum, beneath the patient's sternum. The distal endof the lead can also be positioned so to be aligned with an intercostalspace in the region of the cardiac notch. Other similar placements inthe region of the cardiac notch, adjacent the heart, are alsocontemplated for this particular application of cardiac pacing.

In one exemplary procedure, as shown in FIG. 1, a cardiac pacing lead100 may be inserted within the ribcage 101 of a patient 104 through anintercostal space 108 in the region of the cardiac notch. Lead 100 maybe inserted through an incision 106, for example. The incision 106 maybe made in proximity to the sternal margin to increase the effectivenessin finding the appropriate intercostal space 108 and avoiding certainanatomical features, for example the lung 109. The incision may be madelateral to the sternal margin, adjacent the sternal margin or any otherdirection that facilitates access to an appropriate intercostal space108. A distal end of lead 100 can be positioned to terminate within themediastinum of the thoracic cavity of the patient, proximate the heart118. Lead 100 may then be connected to a pulse generator or controller102, which may be placed above the patient's sternum 110. In alternativeprocedures, for temporary pacing, a separate controller may be used thatis not implanted in the patient.

In some implementations, the pericardium is not invaded by the leadduring or after implantation. In other implementations, incidentalcontact with the pericardium may occur, but heart 118 (contained withinthe pericardium) may remain untouched. In still further procedures,epicardial leads, or leads that reside within the pericardium, which doinvade the pericardium, may be inserted.

FIG. 2A is an illustration of an exemplary lead delivery system 200facilitating delivery of a lead in the region of a cardiac notch. FIG.2A illustrates delivery system 200 and a cross section 201 (includingleft chest 203 and right chest 207) of a patient 104. FIG. 2Aillustrates sternum 110, lung 109, intercostal muscle 108, heart 118,mediastinum 202, pericardium 204, and other anatomical features. Asshown in FIG. 2A, lead delivery system 200 may be configured to allowfor a distal end 206 of delivery system 200 to be pressed against thesternum 110 of patient 104.

In one implementation, a physician identifies an insertion point aboveor adjacent to a patient's sternum 110 and makes an incision. The distalend 206 of delivery system 200 can then be inserted through theincision, until making contact with sternum 110. The physician can thenslide distal end 206 of delivery system 200 across sternum 110 towardthe sternal margin until it drops through the intercostal muscle 108 inthe region of the cardiac notch under pressure applied to the deliverysystem 200 by the physician. FIG. 2B illustrates the distal end 206having dropped through the intercostal muscle in the region of thecardiac notch toward the pericardium.

In certain implementations, delivery system 200 may include anorientation or level guide 316 to aid the physician with obtaining theproper orientation and/or angle of delivery system 200 to the patient.Tilting delivery system 200 to the improper angle may negatively affectthe deployment angle of lead 100 into the patient. For example, ahorizontal level guide 316 on delivery system 200 helps to ensure thatthe physician keeps delivery system 200 level with the patient's sternumthereby ensuring lead 100 is delivered at the desired angle.

Following this placement of delivery system 200, the system may beactuated to insert an electrical lead 100 into the patient. FIG. 2Cillustrates an exemplary electrical lead 100 exiting delivery system 200with two electrodes 210, 212 positioned on one side of lead 100, withinthe mediastinum 202 and facing heart 118. FIG. 2C illustrates the lead100 advancing in a direction away from sternum 110. This example is notintended to be limiting. For example, the lead 100 may also be advancedin a direction parallel to the sternum 110. In some implementations,delivery system 200 may be configured such that lead 100 advances in theopposite direction, under sternum 110, advances away from sternum 110 atan angle that corresponds to an angle of one or more ribs of patient104, and/or advances in other orientations. Similarly, an exemplarydevice as shown in FIG. 2 may be flipped around so that the handle wouldbe on the left side of FIG. 2, or held in other positions by thephysician, prior to system actuation and insertion of lead 100.

Distal end 206 of delivery system 200 may be configured to move orpuncture tissue during insertion, for example, with a relatively blunttip (e.g., as described herein), to facilitate entry into themediastinum without requiring a surgical incision to penetrate throughintercostal muscles and other tissues. A blunt access tip, whileproviding the ability to push through tissue, can be configured to limitthe potential for damage to the pericardium or other critical tissues orvessels that the tip may contact.

In an exemplary implementation, the original incision made by thephysician above or adjacent to the sternum may also be used to insert acontroller, pulse generator or additional electrode to which theimplanted lead may be connected.

The delivery system and lead technologies described herein may beespecially well suited for the cardiac pacing lead delivery exampledescribed above. While this particular application has been described indetail, and may be utilized throughout the descriptions below, it iscontemplated that the delivery system(s) 200 and lead(s) 100 herein maybe utilized in other procedures as well, such as the insertion of adefibrillation lead.

FIG. 3 illustrates an exemplary delivery system 200. Delivery system 200can include a handle 300, a component advancer 302, a first insertiontip 304, a second insertion tip 306, a lock 308, and/or othercomponents. Handle 300 may be configured to be actuated by an operator.In some implementations, handle 300 may be coupled to a body 310 and/orother components of delivery system 200. Body 310 may include an orifice312, finger depressions 314, a knurled surface, a lever arm, and/orother components configured to facilitate gripping of handle 300 by anoperator. In some implementations, handle 300 and the body of thedelivery system 200 may be coated with a material or their surfacescovered with a texture to prevent slippage of the physician's grasp whenusing delivery system 200.

Component advancer 302 may be coupled to handle 300 and configured toadvance a component such as an electrical lead (as one example) into thepatient by applying a force to the portion of the component in responseto actuation of handle 300 by the operator.

First insertion tip 304 and second insertion tip 306 may be configuredto close around a distal tip and/or segment of the component when thecomponent is placed within component advancer 302. In someimplementations, closing around a distal segment of the component mayinclude blocking a path between the component and the environmentoutside delivery system 200. Closing around the distal segment of thecomponent may also prevent the component from being unintentionallydeployed and contacting biological tissue while delivery system 200 isbeing manipulated by the operator.

First insertion tip 304 and second insertion tip 306 may also beconfigured to fully enclose the distal segment of the component when thecomponent is placed within component advancer 302. Fully enclosing thedistal segment of the component may include covering, surrounding,enveloping, and/or otherwise preventing contact between the distalsegment of the component and an environment around first insertion tip304 and second insertion tip 306.

In still other implementations, first insertion tip 304 and secondinsertion tip 306 may be configured to only partially enclose the distalsegment of the component when the component is placed within componentadvancer 302. For example, first insertion tip 304 and/or secondinsertion tip 306 may cover, surround, envelop, and/or otherwise preventcontact between one or more portions (e.g., surfaces, ends, edges, etc.)of the distal segment of the component and the environment around tips304 and 306, but the tips 304 and 306 may also still block the pathbetween the component and the environment outside the delivery system200 during insertion.

In some implementations, first insertion tip 304 and second insertiontip 306 may be configured such that the component is held withincomponent advancer 302 rather than within first insertion tip 304 andsecond insertion tip 306, prior to the component being advanced into thepatient.

First insertion tip 304 and second insertion tip 306 may be furtherconfigured to push through biological tissue when in a closed positionand to open (see, e.g., 320 in FIG. 3) to enable the component to exitfrom the component advancer 302 into the patient. In someimplementations, opening may comprise second insertion tip 306 movingaway from first insertion tip 304, and/or other opening operations. Insome implementations, first and second insertion tips 304, 306 may beconfigured to open responsive to actuation of handle 300.

In some implementations, first insertion tip 304 and/or second insertiontip 306 may be configured to close (or re-close) after the componentexits from the component advancer 302, to facilitate withdrawal ofdelivery system 200 from the patient. Thus, first insertion tip 304 andsecond insertion tip 306 may be configured to move, after the componentexits from component advancer 302 into the patient, to a withdrawalposition to facilitate withdrawal of first insertion tip 304 and secondinsertion tip 306 from the biological tissue. In some implementations,the withdrawal position may be similar to and/or the same as an originalclosed position. In some implementations, the withdrawal position may bea different position. In some implementations, the withdrawal positionmay be wider than the closed position, but narrower than an openposition. For example, first insertion tip 304 and/or second insertiontip 306 may move to the open position to release the component, but thenmove to a different position with a narrower profile (e.g., thewithdrawal position) so that when the tips 304, 306 are removed they arenot met with resistance pulling through a narrow rib space, and/or otherbiological tissue.

In some implementations, first and second insertion tips 304, 306 mayhave blunt edges. Blunt edges may include rounded and/or otherwise dulledges, corners, surfaces, and/or other components of first and secondinsertion tips 304, 306. The blunt edges may be configured to preventinsertion tips 304 and 306 from rupturing any veins or arteries, thepericardial sac, the pleura of the lungs, and/or causing any otherunintentional damage to biological tissue. The blunt edges may prevent,for example, rupturing veins and/or arteries by pushing these vascularitems to the side during insertion. The blunt edges may also prevent,for example, the rupturing of the pericardium or pleura because they arenot sharp.

FIG. 4 illustrates first and second insertion tips 304, 306 withexemplary implementations of such blunt edges. As shown in FIG. 4, firstand second insertion tips 304, 306 may have rounded corners 400, 402and/or end surfaces 401, 403 at their respective ends 404, 406. Firstand second insertion tips 304, 306 may have rounded edges 408, 410 thatrun along a longitudinal axis of tips 304, 306. However, thisdescription is not intended to be limiting. In some implementations,first and second insertion tips 304, 306 may also have sharp edges,ends, and/or other features.

In some implementations, first and second insertion tips 304, 306 mayeach include a channel at least partially complimentary to a shape ofthe component and configured to guide the component into the patient.FIG. 5 illustrates an example of such a channel. As shown in FIG. 5,first insertion tip 304 may include a channel 500 at least partiallycomplimentary to a shape of the component and configured to guide thecomponent into the patient. Second insertion tip 306 may also include achannel similar to and/or the same as channel 500 (although the channelin insertion tip 306 is not visible in FIG. 5). Channel 500 may extendalong a longitudinal axis of insertion tip 304 from an end 502 ofinsertion tip 304 configured to couple with component advancer 302toward end 404.

In some implementations, channel 500 may be formed by a hollow area ofinsertion tip 304 that forms a trench, for example. The hollow areaand/or trench may have one or more shapes and/or dimensions that are atleast partially complimentary to a shape and/or dimension(s) of thecomponent, and are configured to guide the component into the patient.In some implementations, the hollow area and/or trench may be configuredsuch that the component may only slide within channel 500 inside theinsertion tips 304, 306, and therefore prevent the component fromadvancing out one of the sides of the insertion tips 304, 306 whenpushed by component advancer 302.

In some implementations, channel 500 may include a second channel and/orgroove configured to engage alignment features included on a component.The second channel or groove may be located within channel 500, but bedeeper and/or narrower than channel 500. The component may then includea rib and/or other alignment features configured to engage such agroove. The rib may be on an opposite side of the component relative toelectrodes, for example. These features may enhance the guidance of acomponent through channel 500, facilitate alignment of a component inchannel 500 (e.g., such that the electrodes are oriented in a specificdirection in tips 304, 306, preventing the component from exiting tips304, 306 to one side or the other (as opposed to exiting out ends 404,406), and/or have other functionalities.

In some implementations, the second channel and/or groove may be sizedto be just large enough to fit an alignment feature of the componentwithin the second channel and/or groove. This may prevent an operatorfrom pulling a component too far up into delivery system 200 (FIG. 3)when loading delivery system 200 with a component (e.g., as describedbelow).

The channels and/or grooves may also provide a clinical benefit. Forexample, the channel and/or groove may allow for narrower insertion tips304 and 306 that need not be configured to surround or envelop all sidesof the component (e.g., they may not need sidewalls to keep thecomponent in position during implantation). If surrounding or envelopingall sides of a component is necessary, the insertion tips would need tobe larger, and would meet with greater resistance when separating tissueplanes within intercostal spaces, for example. However, in otherimplementations (e.g., as described herein), insertion tips 304, 306 maycompletely surround and/or envelop the component.

In some implementations, as shown in FIG. 6, a first insertion tip 304may be longer than a second insertion tip 306 and the end 404 of firstinsertion tip 304 will extend beyond the end 406 of insertion tip 306.Such a configuration may assist with spreading of tissue planes and helpto avoid pinching tissue, veins, arteries or the like while deliverysystem 200 is being manipulated through biological tissue.

In some implementations, both the first and second insertion tips 304,306 may be moveable. In other implementations, the first insertion tip304 may be fixed, and second insertion tip 306 may be moveable.

In one particular implementation, a fixed insertion tip 304 may belonger than a movable insertion tip 306. This configuration may allowmore pressure to be exerted on the outermost edge (e.g., end 404 of tip304) of delivery system 200 without (or with reduced) concern that tips304 and 306 will open when pushing through biological tissue.Additionally, the distal ends 404 and 406 may form an underbite 600 thatallows distal end 406 of movable insertion tip 306 (in this example) toseat behind fixed insertion tip 304, and thus prevent tip 406 fromexperiencing forces that may inadvertently open movable insertion tip306 during advancement. However, this description is not intended to belimiting. In some implementations, a movable insertion tip 306 may belonger than a fixed insertion tip 304.

In some implementations, a fixed (e.g., and/or longer) insertion tip 304may include a ramped portion configured to facilitate advancement of thecomponent into the patient in a particular direction. FIG. 7 illustratesan example of a ramped portion 700 of insertion tip 304. Ramped portion700 may be located on an interior surface 702 of insertion tip 304,between channel 500 and distal end 404 of insertion tip 304. Rampedportion 700 may be configured to facilitate advancement of the componentinto the patient in a particular direction. The particular direction maybe a lateral direction relative to a position of insertion tip 304, forexample. The lateral deployment of a component (e.g., an electricallead) when it exits insertion tip 304 and moves into the anteriormediastinum of the patient may facilitate deployment without contactingthe heart (e.g., as described relative to FIGS. 2A-2C above). Rampedportion 700 may also encourage the component to follow a preformed bias(described below) and help prevent the lead from deploying in anunintentional direction.

In some implementations, insertion tips 304, 306 may have open sidewalls. FIG. 8 illustrates an example of insertion tips 304, 306 withopen side walls 800, 802. FIG. 8 illustrates a cross sectional view ofinsertion tips 304, 306, looking at insertion tips 304, 306 from distalends 404, 406 (as shown in FIG. 7). Open side walls 800, 802 may beformed by spaces between insertion tip 304 and insertion tip 306. In theexample of FIG. 8, insertion tips 304 and 306 are substantially “U”shaped, with the ends 804, 806, 808, 810 extending toward each other,but not touching, such that open side walls 800 and 802 may be formed.Open side walls 800, 802 may facilitate the use of a larger component(e.g., a component that does not fit within channel(s) 500), withouthaving to increase a size (e.g., a width, etc.) of insertion tips 304,306. This may avoid effects larger insertion tips may have on biologicaltissue. For example, larger insertion tips are more invasive thansmaller insertion tips. As such, larger insertion tips may meet withgreater resistance when separating tissue planes within intercostalspaces during deployment and may cause increased trauma than insertiontips having a reduced cross sectional size.

In some implementations, delivery system 200 (FIG. 3) may include ahandle 300 (FIG. 3), a component advancer 302 (FIG. 3), and a unitaryinsertion tip (e.g., instead of first and second insertion tips 304 and306). FIG. 9A illustrates one possible example of a delivery system 200having a unitary insertion tip 900. Insertion tip 900 may be coupled toa component advancer 302 similar to and/or in the same manner thatinsertion tips 304 and 306 (FIG. 7) may be coupled to component advancer302.

Unitary insertion tip 900 may have a circular, rectangular, wedge,square, and/or other cross sectional shape(s). In some implementations,insertion tip 900 may form a (circular or rectangular, etc.) tubeextending along a longitudinal axis 902 (FIG. 9B) of insertion tip 900.Referring to FIG. 9B, in some implementations, insertion tip 900 may beconfigured to hold the component (labeled as 904) when the component isplaced within component advancer 302. In some implementations, insertiontip 900 may be configured to hold a distal end (labeled as 906) and/ortip of component 904 when component 904 is placed within componentadvancer 302.

Insertion tip 900 may be configured to push through biological tissueand may include a distal orifice 908 configured to enable component 904to exit from component advancer 302 into the patient.

FIG. 9C illustrates an alternative insertion tip 900 design having awedge shape. A wedge-shaped insertion tip 900 reduces and/or eliminatesthe exposure of distal orifice 908 to the surrounding tissue duringinsertion. This design prevents tissue coring since only the leadingedge of insertion tip 900 is exposed and thereby separates tissuesrather than coring or cutting tissue during insertion. Accordingly, thepresent disclosure contemplates an insertion tip that may be configuredto reduce the exposure of the distal orifice during insertion.

Referring to FIG. 9D, distal tip 912 may be rounded into an arc so thedeployment force exerted by the physician during insertion concentratesin a smaller area (the distalmost portion of distal tip 912).Additionally, the distalmost portion of distal tip 912 may be blunted tominimize trauma and damage to surrounding tissue during insertion. Notch914 provides additional room for the proximal end of lead 100 having arigid electrical connector to more easily be inserted when loading lead100 in delivery system 200. Rails 916 overlap lead 100 and hold lead 100flat when the lead is retracted and held within delivery system 200. Insome implementations, the inner edge of rails 916 gradually widen asrails 916 advance toward distal tip 912.

FIG. 9D illustrates certain features applicable to a unitary insertiontip design.

In some implementations, insertion tip 900 may include a movable cover918 configured to prevent the biological tissue from entering distalorifice 908 when insertion tip 900 pushes through the biological tissue.The moveable cover may move to facilitate advancement of component 904into the patient.

It is contemplated that many of the other technologies disclosed hereincan also be used with the unitary tip design. For example, insertion tip900 may include a ramped portion 910 configured to facilitateadvancement of the component into the patient in a particular directionand to allow the protruding electrodes 210, 212 to pass easier throughthe channel created within insertion tip 900.

In some implementations, delivery system 200 (FIG. 3) may include adilator. In some implementations, insertion tips 304, 306, and/orinsertion tip 900 may operate in conjunction with such a dilator. Use ofa dilator may allow an initial incision to be smaller than it mayotherwise be. The dilator may be directionally oriented to facilitateinsertion of a component (e.g., an electrical lead) through thepositioned dilator manually, and/or by other means. The dilator maycomprise a mechanism that separates first and second insertion tips 304,306. For example, relatively thin first and second insertion tips 304,306 may be advanced through biological tissue. An actuator (e.g., ahandle, and/or a device couple to the handle operated by the user) mayinsert a hollow, dilating wedge that separates first and secondinsertion tips 304, 306. The actuator (operated by the user) may advancea lead through the hollow dilator into the biological tissue. Thedilator may also be used to separate the first and second insertion tips304, 306 such that they lock into an open position. The dilator can thenbe removed and the lead advanced into the biological tissue.

FIGS. 10 and 11 illustrate an exemplary lock 1000 that may be includedin delivery system 200. A lock 1000 may be similar to and/or the same aslock 308 shown in FIG. 3. In some implementations, lock 1000 may beconfigured to be moved between an unlocked position that allowsactuation of handle 300 (and in turn component advancer 302) by theoperator and a locked position that prevents actuation, and preventsfirst insertion tip 304 (FIG. 7) and second insertion 306 tip (FIG. 7)from opening.

FIG. 10 illustrates lock 1000 in a locked position 1002. FIG. 11illustrates lock 1000 in an unlocked position 1004. Lock 1000 may becoupled to handle 300 and/or component advancer 302 via a hinge 1003and/or other coupling mechanisms. In some implementations, lock 1000 maybe moved from locked position 1002 to unlocked position 1004, and viceversa, by rotating and/or otherwise moving an end 1006 of lock 1000 awayfrom handle 300 (see, e.g., 1005 in FIG. 11). Lock 1000 may be movedfrom locked position 1002 to unlocked position 1004, and vice versa, bythe operator with thumb pressure, trigger activation (button/lever,etc.) for example, and/or other movements. Additionally, the mechanismmay also include a safety switch such that a trigger mechanism must bedeployed prior to unlocking the lock with the operator's thumb.

When lock 1000 is engaged or in locked position 1002, lock 1000 mayprevent an operator from inadvertently squeezing handle 300 to deploythe component. Lock 1000 may prevent the (1) spreading of the distaltips 304, 306, and/or (2) deployment of a component while deliverysystem 200 is being inserted through the intercostal muscles.

Lock 1000 may be configured such that deployment of the component mayoccur only when lock 1000 is disengaged (e.g., in the unlocked position1004 shown in FIG. 11). Deployment may be prevented, for example, whilean operator is using insertion tips 304, 306 of delivery system 200 toslide between planes of tissue in the intercostal space as pressure isapplied to delivery system 200. Lock 1000 may be configured such that,only once system 200 is fully inserted into the patient can lock 1000 bemoved so that handle 300 may be actuated to deliver the componentthrough the spread (e.g., open) insertion tips 304, 306. It should benoted that the specific design of lock 1000 shown in FIGS. 10 and 11 isnot intended to be limiting. Other locking mechanism designs arecontemplated. For example, the lock 1000 may be designed so that lock1000 must be fully unlocked to allow the handle 300 to be deployed. Apartial unlocking of lock 1000 maintains the handle in the lockedposition as a safety mechanism. Furthermore, the lock 1000 may beconfigured such that any movement from its fully unlocked position willrelock the handle 300.

Returning to FIG. 3, component advancer 302 may be configured to advancea component into a patient. The component may be an electrical lead(e.g., as described herein), and/or other components.

The component advancer 302 may be configured to removably engage aportion of the component, and/or to deliver the component into thepatient through insertion tips 304 and 306. In some implementations,component advancer 302 and/or other components of system 200 may includeleveraging components configured to provide a mechanical advantage or amechanical disadvantage to an operator such that actuation of handle 300by the operator makes advancing the component into the patient easier ormore difficult. For example, the leveraging components may be configuredsuch that a small and/or relatively light actuation pressure on handle300 causes a large movement of a component (e.g., full deployment) fromcomponent advancer 302. Or, in contrast, the leveraging components maybe configured such that a strong and/or relatively intense actuationpressure is required to deliver the component. In some implementations,the leveraging components may include levers, hinges, wedges, gears,and/or other leveraging components (e.g., as described herein). In someimplementations, handle 300 may be advanced in order to build up torqueonto component advancer 302, without moving the component. Oncesufficient torque has built up within the component advancer, themechanism triggers the release of the stored torque onto the componentadvancer, deploying the component.

In some implementations, component advancer 302 may include a rack andpinion system coupled to handle 300 and configured to grip the componentsuch that actuation of handle 300 by the operator causes movement of thecomponent via the rack and pinion system to advance the component intothe patient. In some implementations, the rack and pinion system may beconfigured such that movement of handle 300 moves a single or dual rackincluding gears configured to engage and rotate a single pinion ormultiple pinions that engage the component, so that when the singlepinion or multiple pinions rotate, force is exerted on the component toadvance the component into the patient.

FIG. 12A illustrates an exemplary rack and pinion system 1200. Rack andpinion system may include rack(s) 1202 with gears 1204. Example system1200 includes two pinions 1206, 1208. Pinions 1206 and 1208 may beconfigured to couple with a component 1210 (e.g., an electrical lead),at or near a distal end 1212 of component 1210, as shown in FIG. 12A.Rack and pinion system 1200 may be configured such that movement ofhandle 300 moves rack 1202 comprising gears 1204 configured to engageand rotate pinions 1206, 1208 that engage component 1210, so that whenpinions 1206, 1208 rotate 1214, force is exerted 1216 on component 1210to advance component 1210 into the patient.

In some implementations, responsive to handle 300 being actuated, acomponent (e.g., component 1210) may be gripped around a length of abody of the component, as shown in FIG. 12B. The body of the componentmay be gripped by two opposing portions 1250, 1252 of component advancer302 that engage either side of the component, by two opposing portionsthat engage around an entire circumferential length of a portion of thebody, and/or by other gripping mechanisms.

Once gripped, further actuation of handle 300 may force the two opposingportions within component advancer 302 to traverse toward a patientthrough delivery system 200. Because the component may be secured bythese two opposing portions, the component may be pushed out of deliverysystem 200 and into the (e.g., anterior mediastinum) of the patient. Byway of a non-limiting example, component advancer 302 may comprise aclamp 1248 having a first side 1250 and a second side 1252 configured toengage a portion of the component. Clamp 1248 may be coupled to handle300 such that actuation of handle 300 by the operator may cause movementof the first side 1250 and second side 1252 of clamp 1248 to push on theportion of the component to advance the component into the patient. Uponadvancing the component a fixed distance (e.g., distance 1254) into thepatient, clamp 1248 may release the component. Other gripping mechanismsare also contemplated.

Returning to FIG. 3, in some implementations, component advancer 302 mayinclude a pusher tube coupled with handle 300 such that actuation ofhandle 300 by the operator causes movement of the pusher tube to push onthe portion of the component to advance the component into the patient.In some implementations, the pusher tube may be a hypo tube, and/orother tubes. In some implementations, the hypo tube may be stainlesssteel and/or be formed from other materials. However, these examples arenot intended to be limiting. The pusher tube may be any tube that allowssystem 200 to function as described herein.

FIGS. 13 and 14 illustrate different views of an exemplaryimplementation of a component advancer 302 including a pusher tube 1300coupled with handle 300. As shown in FIG. 13, in some implementations,pusher tube 1300 may include a notch 1302 having a shape complementaryto a portion of a component and configured to maintain the component ina particular orientation so as to avoid rotation of the component withinsystem 200. FIG. 13 shows notch 1302 formed in a distal end 1304 ofpusher tube 1300 configured to mate and/or otherwise engage with an endof a distal portion of a component (not shown in FIG. 13) to beimplanted. Pusher tube 1300 may be configured to push, advance, and/orotherwise propel a component toward and/or into a patient via notch 1302responsive to actuation of handle 300.

In some implementations, the proximal end 1308 of pusher tube 1300 maybe coupled to handle 300 via a joint 1310. Joint 1310 may be configuredto translate articulation of handle 300 by an operator into movement ofpusher tube 1300 toward a patient. Joint 1310 may include one or more ofa pin, an orifice, a hinge, and/or other components. In someimplementations, component advancer 302 may include one or more guidecomponents 1314 configured to guide pusher tube 1300 toward the patientresponsive to the motion translation by joint 1310. In someimplementations, guide components 1314 may include sleeves, clamps,clips, elbow shaped guide components, and/or other guide components.Guide components 1314 may also add a tensioning feature to ensure theproper tactile feedback to the physician during deployment. For example,if there is too much resistance through guide components 1314, then thehandle 300 will be too difficult to move. Additionally, if there is toolittle resistance through the guide components 1314, then the handle 300will have little tension and may depress freely to some degree whendelivery system 200 is inverted.

FIG. 14 provides an enlarged view of distal end 1304 of pusher tube1300. As shown in FIG. 14, notch 1302 is configured with a rectangularshape. This rectangular shape is configured to mate with and/orotherwise engage a corresponding rectangular portion of a component(e.g., as described below). The rectangular shape is configured tomaintain the component in a specific orientation. For example,responsive to a component engaging pusher tube 1300 via notch 1302,opposing (e.g., parallel in this example) surfaces, and/or theperpendicular (in this example) end surface of the rectangular shape ofnotch 1302 may be configured to prevent rotation of the component. Thisnotch shape is not intended to be limiting. Notch 1302 may have anyshape that allows it to engage a corresponding portion of a componentand prevent rotation of the component as described herein. For example,in some implementations, pusher tube 1300 may include one or morecoupling features (e.g., in addition to or instead of the notch)configured to engage the portion of the component and configured tomaintain the component in a particular orientation so as to avoidrotation of the component within system 200. These coupling features mayinclude, for example, mechanical pins on either side of the pusher tube1300 configured to mate with and/or otherwise engage receptacle featureson a corresponding portion of a component.

FIG. 15 illustrates insertion tips 304 and 306 in an open position 1502.FIG. 15 also illustrates pusher tube 1300 in an advanced position 1500,caused by actuation of handle 300 (not shown). Advanced position 1500 ofpusher tube 1300 may be a position that is closer to insertion tips 304,306 relative to the position of pusher tube 1300 shown in FIG. 14.

In some implementations, the component advancer 302 may include a wedge1506 configured to move insertion tip 304 and/or 306 to the openposition 1502. In some implementations, wedge 1506 may be configured tocause movement of the moveable insertion tip 306 and may or may notcause movement of insertion tip 304.

Wedge 1506 may be coupled to handle 300, for example, via a joint 1510and/or other components. Joint 1510 may be configured to translatearticulation of handle 300 by an operator into movement of the wedge1506. Joint 1510 may include one or more of a pin, an orifice, a hinge,and/or other components. Wedge 1506 may be designed to include anelongated portion 1507 configured to extend from joint 1510 towardinsertion tip 306. In some implementations, wedge 1506 may include aprotrusion 1509 and/or other components configured to interact withcorresponding parts 1511 of component advancer 302 to limit a traveldistance of wedge 1506 toward insertion tip 306 and/or handle 300.

Wedge 1506 may also be slidably engaged with a portion 1512 of moveableinsertion tip 306 such that actuation of handle 300 causes wedge 1506 toslide across portion 1512 of moveable insertion tip 306 in order to movemoveable insertion tip 306 away from fixed insertion tip 304. Forexample, insertion tip 306 may be coupled to component advancer 302 viaa hinge 1520. Wedge 1506 sliding across portion 1512 of moveableinsertion tip 306 may cause moveable insertion tip to rotate about hinge1520 to move moveable insertion tip 306 away from fixed insertion tip304 and into open position 1502. In some implementations, moveableinsertion tip 306 may be biased to a closed position. For example, aspring mechanism 1350 (also labeled in FIGS. 13 and 14) and/or othermechanisms may perform such biasing for insertion tip 306. Springmechanism 1350 may force insertion tip 306 into the closed positionuntil wedge 1506 is advanced across portion 1512, thereby separatinginsertion tip 306 from insertion tip 304.

In some implementations, as described above, first insertion tip 304 andsecond insertion tip 306 may be moveable. In some implementations, firstinsertion tip 304 and/or second insertion tip 306 may be biased to aclosed position. For example, a spring mechanism similar to and/or thesame as spring mechanism 1350 and/or other mechanisms may perform suchbiasing for first insertion tip 304 and/or second insertion tip 306. Insuch implementations, system 200 may comprise one or more wedges similarto and/or the same as wedge 1506 configured to cause movement of firstand second insertion tips 304, 306. The one or more wedges may becoupled to handle 300 and slidably engaged with first and secondinsertion tips 304, 306 such that actuation of handle 300 may cause theone or more wedges to slide across one or more portions of first andsecond insertion tips 304, 306 to move first and second insertion tips304, 306 away from each other.

In some implementations, system 200 may comprise a spring/lock mechanismor a rack and pinion system configured to engage and cause movement ofmoveable insertion tip 306. The spring/lock mechanism or the rack andpinion system may be configured to move moveable insertion tip 306 awayfrom fixed insertion tip 304, for example. A spring lock design mayinclude design elements that force the separation of insertion tips 304and 306. One such example may include spring forces that remain lockedin a compressed state until the component advancer or separating wedgeactivate a release trigger, thereby releasing the compressed springforce onto insertion tip 306, creating a separating force. These springforces must be of sufficient magnitude to create the desired separationof tips 304 and 306 in the biological tissue. Alternatively, the springcompression may forceable close the insertion tips until the closingforce is released by the actuator. Once released, the tips are thendriven to a separating position by the advancement wedge mechanism, asdescribed herein.

In some implementations, the component delivered by delivery system 200(e.g., described above) may be an electrical lead for implantation inthe patient. The lead may comprise a distal portion, one or moreelectrodes, a proximal portion, and/or other components. The distalportion may be configured to engage component advancer 302 of deliverysystem 200 (e.g., via notch 1302 shown in FIGS. 13 and 14). The distalportion may comprise the one or more electrodes. For example, the one ormore electrodes may be coupled to the distal portion. The one or moreelectrodes may be configured to generate therapeutic energy forbiological tissue of the patient. The therapeutic energy may be, forexample, electrical pulses and/or other therapeutic energy. Thebiological tissue may be the heart (e.g., heart 118 shown in FIG. 1-FIG.2C) and/or other biological tissue. The proximal portion may be coupledto the distal portion. The proximal portion may be configured to engagea controller when the lead is implanted in the patient. The controllermay be configured to cause the one or more electrodes to generate thetherapeutic energy, and/or perform other operations.

FIG. 16 illustrates an example implementation of an electrical lead1600. Lead 1600 may comprise a distal portion 1602, one or moreelectrodes 1604, a proximal portion 1606, and/or other components.Distal portion 1602 may be configured to engage component advancer 302of delivery system 200 (e.g., via notch 1302 shown in FIGS. 13 and 14).In some implementations, distal portion 1602 may comprise a proximalshoulder 1608. Proximal shoulder may be configured to engage componentadvancer 302 (e.g., via notch 1302 shown in FIGS. 13 and 14) such thatlead 1600 is maintained in a particular orientation when lead 1600 isadvanced into the patient. For example, in some implementations,proximal shoulder 1608 may comprise a flat surface 1610 (e.g., at aproximal end of distal portion 1602). In some implementations, proximalshoulder 1608 may comprise a rectangular shape 1612. Flat surface 1610and/or rectangular shape 1612 may be configured to correspond to a(e.g., rectangular) shape of notch 1302 shown in FIGS. 13 and 14. Insome implementations, transition surfaces between flat surface 1610 andother portions of distal portion 1602 may be chamfered, rounded,tapered, and/or have other shapes.

In some implementations, proximal shoulder 1608 may include one or morecoupling features configured to engage component advancer 302 tomaintain the lead in a particular orientation so as to avoid rotation ofthe lead when the lead is advanced into the patient. In someimplementations, these coupling features may include receptacles forpins included in pusher tube 1300, clips, clamps, sockets, and/or othercoupling features.

In some implementations, proximal shoulder 1608 may comprise the samematerial used for other portions of distal portion 1602. In someimplementations, proximal shoulder may comprise a more rigid material,and the material may become less rigid across proximal shoulder 1608toward distal end 1620 of distal portion 1602.

In some implementations, proximal shoulder 1608 may function as afixation feature configured to make removal of lead 1600 from a patient(and/or notch 1302) more difficult. For example, when lead 1600 isdeployed into the patient, lead 1600 may enter the patient led by adistal end 1620 of the distal portion 1602. However, retracting lead1600 from the patient may require the retraction to overcome the flatand/or rectangular profile of flat surface 1610 and/or rectangular shape1612, which should be met with more resistance. In some implementations,delivery system 200 (FIG. 3) may include a removal device comprising asheath with a tapered proximal end that can be inserted over lead 1600so that when it is desirable to intentionally remove lead 1600, the flatand/or rectangular profile of shoulder 1608 does not interact with thetissue on the way out.

FIG. 17 illustrates another example implementation 1700 of electricallead 1600. In some implementations, as shown in FIG. 17, distal portion1602 may include one or more alignment features 1702 configured toengage delivery system 200 (FIG. 3) in a specific orientation. Forexample, alignment features 1702 of lead 1600 may include a rib 1704and/or other alignment features configured to engage a groove in achannel (e.g., channel 500 shown in FIG. 5) of insertion tip 304 and/or306 (FIG. 5). Rib 1704 may be on an opposite side 1706 of the lead 1600relative to a side 1708 with electrodes 1604, for example. Thesefeatures may enhance the guidance of lead 1600 through channel 500,facilitate alignment of lead 1600 in channel 500 (e.g., such thatelectrodes 1604 are oriented in a specific direction in tips 304, 306),prevent lead 1600 from exiting tips 304, 306 to one side or the other(as opposed to exiting out ends 404, 406 shown in FIG. 4), and/or haveother functionality.

In some implementations, rib 1704 may be sized to be just large enoughto fit within the groove in the channel 500. This may prevent the leadfrom moving within the closed insertion tips 304, 306 while theinsertion tips are pushed through the intercostal muscle tissue.Additionally, rib 1704 may prevent an operator from pulling lead 1600too far up into delivery system 200 (FIG. 3) when loading deliverysystem 200 with a lead (e.g., as described below). This may provide aclinical benefit, as described above, and/or have other advantages.

FIG. 18 illustrates distal portion 1602 of lead 1600 bent 1800 in apredetermined direction 1804. In some implementations, distal portion1602 may be pre-formed to bend in predetermined direction 1804. Thepre-forming may shape set distal portion 1602 with a specific shape, forexample. In the example, shown in FIG. 18, the specific shape may forman acute angle 1802 between ends 1620, 1608 of distal portion 1602. Thepre-forming may occur before lead 1600 is loaded into delivery system200 (FIG. 3), for example. In some implementations, distal portion 1602may comprise a shape memory material configured to bend in predetermineddirection 1804 when lead 1600 exits delivery system 200. The shapememory material may comprise nitinol, a shape memory polymer, and/orother shape memory materials, for example. The preforming may includeshape setting the shape memory material in the specific shape beforelead 1600 is loaded into delivery system 200.

Distal portion 1602 may be configured to move in an opposite direction1806, from a first position 1808 to a second position 1810 when lead1600 enters the patient. In some implementations, first position 1808may comprise an acute angle 1802 shape. In some implementations, thefirst position may comprise a ninety degree angle 1802 shape, or anobtuse angle 1802 shape. In some implementations, the second positionmay comprise a ninety degree angle 1802 shape, or an obtuse angle 1802shape. Distal portion 1602 may be configured to move from first position1808 to second position 1810 responsive to the shape memory materialbeing heated to body temperature or by removal of an internal wirestylet, for example. In some implementations, this movement may cause anelectrode side of distal portion 1602 to push electrodes 1604 intotissues toward a patient's heart, rather than retract away from suchtissue and the heart. This may enhance electrical connectivity and/oraccurately delivering therapeutic energy toward the patient's heart, forexample.

FIG. 19 illustrates distal portion 1602 bending 1800 in thepredetermined direction 1804 when lead 1600 exits delivery system 200.In some implementations, as shown in FIG. 19, the predetermineddirection may comprise a lateral and/or transverse direction 1900relative to an orientation 1902 of insertion tips 304 and/or 306, asternum of the patient, and/or other reference points in delivery system200 and/or in the patient.

FIGS. 20 and 21 illustrate implementations 2000 and 2100 of distalportion 1602 of lead 1600. In some implementations, distal portion 1602may include distal end 1620 and distal end 1620 may include a flexibleportion 2002 so as to allow distal end 1620 to change course whenencountering sufficient resistance traveling through the biologicaltissue of the patient. In some implementations, distal end 1620 may beat least partially paddle shaped, and/or have other shapes. The paddleshape may allow more surface area of distal end 1620 to contact tissueso the tissue is then exerting more force back on distal end 1620,making distal end 1620 bend and flex via flexible portion 2002. In someimplementations, flexible portion 2002 may comprise a material thatflexes more easily relative to a material of another area of distalportion 1602. For example, flexible portion 2002 may comprise adifferent polymer relative to other areas of distal portion 1602, ametal, and/or other materials.

In some implementations, flexible portion 2002 may comprise one or morecutouts 2004. The one or more cutouts 2004 may comprise one or moreareas having a reduced cross section compared to other areas of distalportion 1602. The one or more cutouts 2004 may be formed by taperingportions of distal portion 1602, removing material from distal portion1602, and/or forming cutouts 2004 in other ways. The cutouts mayincrease the flexibility of distal end 1620, increase a surface area ofdistal end 1620 to drive distal end 1620 in a desired direction, and/orhave other purposes. Cutouts 2004 may reduce a cross-sectional area ofdistal end 1620, making distal end 1620 more flexible, and making distalend 1620 easier to deflect. Without such cutouts, for example, distalend 1620 may be too rigid or strong, and drive lead 1600 in a directionthat causes undesirable damage to organs and/or tissues within theanterior mediastinum (e.g., the pericardium or heart).

In some implementations, the one or more areas having the reduced crosssection (e.g., the cutouts) include a first area (e.g., cutout) 2006 ona first side 2008 of distal end 1620. The one or more areas having thereduced cross section (e.g., cutouts) may include first area 2006 onfirst side 2008 of distal end 1620 and a second area 2010 on a second,opposite side 2012 of distal end 1620. This may appear to form a neckand/or other features in distal portion 1602, for example.

In some implementations, as shown in FIG. 21, the one or more areashaving the reduced cross section may include one or more cutouts 2100that surround distal end 1620. Referring back to FIG. 18, in someimplementations, distal portion 1602 may have a surface 1820 thatincludes one or more electrodes 1604, and a cut out 1822 in a surface1824 of distal end 1620 opposite surface 1820 with one or moreelectrodes 1604. This positioning of cutout 1822 may promote a bias ofdistal end 1620 back toward proximal shoulder 1608 (FIG. 16) of lead1600. In some implementations, cutout 1822 may create a bias (dependingupon the location of cutout 2100) acutely in direction 1804 or obtuselyin direction 1806. Similarly, alternative cutouts 2100 may be insertedto bias distal end 1620 in other directions.

Returning to FIGS. 20 and 21, in some implementations, flexible portion2002 may be configured to cause distal end 1620 to be biased to changecourse in a particular direction. Distal end 1620 may change course in aparticular direction responsive to encountering resistance frombiological tissue in a patient, for example. In some implementations,biasing distal end 1620 to change course in a particular direction maycomprise biasing distal end 1620 to maintain electrodes 1604 on a sideof distal portion 1602 that faces the heart of the patient. For example,distal end 1620 may be configured to flex or bend to push through aresistive portion of biological material without twisting or rotating tochange an orientation of electrodes 1604.

In some implementations, distal portion 1602 may include a distal tip2050 located at a tip of distal end 1620. Distal tip 2050 may be smallerthan distal end 1620. Distal tip 2050 may be more rigid compared toother portions of distal end 2050. For example, distal tip 2050 may beformed from metal (e.g., that is harder than other metal/polymers usedfor other portions of distal end 1620), hardened metal, a ceramic, ahard plastic, and/or other materials. In some implementations, distaltip 2050 may be blunt, but configured to push through biological tissuesuch as the endothoracic fascia, and/or other biological tissue. In someimplementations, distal tip 2050 may have a hemispherical shape, and/orother blunt shapes that may still push through biological tissue.

In some implementations, distal tip 2050 may be configured to functionas an electrode (e.g., as described herein). This may facilitatemultiple sense/pace vectors being programmed and used without the needto reposition electrical lead 1600. For example, once the electricallead 1600 is positioned, electrical connections can be made to theelectrodes 1604 and cardiac pacing and sensing evaluations performed. Ifunsatisfactory pacing and/or sensing performance is noted, an electricalconnection may be switched from one of the electrodes 1604 to the distalelectrode 2050. Cardiac pacing and/or sensing parameter testing may thenbe retested between one of the electrodes 1604 and the distal electrode2050. Any combination of two electrodes can be envisioned for thedelivery of electrical therapy and sensing of cardiac activity,including the combination of multiple electrodes to create one virtualelectrode, then used in conjunction with a remaining electrode orelectrode pairing. Additionally, electrode pairing may be selectivelyswitched for electrical therapy delivery vs. physiological sensing.

Returning to FIG. 16, in some implementations, at least a portion ofdistal portion 1602 of lead 1600 may comprise two parallel planarsurfaces 1650. One or more electrodes 1604 may be located on one of theparallel planar surfaces, for example. Parallel planar surfaces 1650 maycomprise elongated, substantially flat surfaces, for example. (Only oneparallel planar surface 1650 is shown in FIG. 16. The other parallelplanar surface 1650 may be located on a side of distal portion 1602opposite electrodes 1604, for example.) In some implementations, atleast a portion 1652 of distal portion 1602 of lead 1600 may comprise arectangular prism including the two parallel planar surfaces 1650.

Because the proximal end of the distal portion 1602 may be positionedwithin the intercostal muscle tissue (while the distal end of the distalportion 1602 resides in the mediastinum), the elongated, substantiallyflat surfaces of proximal end of the distal portion 1602 may reduceand/or prevent rotation of distal portion 1602 within the muscle tissueand within the mediastinum. In contrast, a tubular element may be freeto rotate. In some implementations, distal portion 1602 may include oneor more elements configured to engage and/or catch tissue to preventrotation, prevent egress and/or further ingress of distal portion 1602,and/or prevent other movement. Examples of these elements may includetines, hooks, and/or other elements that are likely to catch and/or holdonto biological tissue. In some implementations, the bending of distalportion 1602 (e.g., as described above related to FIG. 18) may alsofunction to resist rotation and/or other unintended movement of distalportion 1602 in a patient. Distal portion 1602 may also be designed withmultiple segments, with small separating gaps between each segment,designed to increase stability within the tissue, increase the forcerequired for lead retraction or to promote tissue ingrowth within thedistal portion 1602.

FIG. 22 illustrates an example of an electrode 1604. In someimplementations, an electrode 1604 may be formed from a conductive metaland/or other materials. Electrodes 1604 may be configured to couple withdistal portion 1602 of lead 1600, proximal portion 1606 (e.g., wiringconfigured to conduct an electrical signal from a controller) of lead1600, and/or other portions of lead 1600. In some implementations,distal portion 1602 may comprise a rigid material, with an area ofdistal portion 1602 around electrodes 1604 comprising a relativelysofter material. One or more electrodes 1604 may protrude from distalportion 1602 of lead 1600 (e.g., as shown in FIG. 16). Electrodes 1604may be configured to provide electrical stimulation to the patient or tosense electrical or other physiologic activity from the patient (e.g.,as described above). In some implementations, one or more electrodes1604 may include one or both of corners 2200 and edges 2202 configuredto enhance a current density in one or more electrodes 1604. In someimplementations, at least one of the electrodes 1604 may comprise one ormore channels 2204 on a surface 2206 of the electrode 1604. In someimplementations, at least one of the one or more electrodes 1604 maycomprise two intersecting channels 2204 on surface 2206 of the electrode1604. In some implementations, the channels 2204 may be configured toincrease a surface area of an electrode 1604 that may come into contactwith biological tissue of a patient. Other channel designs arecontemplated.

FIG. 23 illustrates a cross section 2300 of example electrode 1604. Insome implementations, as shown in FIG. 23, at least one of the one ormore electrodes 1604 may be at least partially hollow 2302. In suchimplementations, an electrode 1604 may include a hole 2304 configured toallow the ingress of fluid. In some implementations, an electrode 1604may include a conductive mesh (not shown in FIG. 23) within hollow area2302. The conductive mesh may be formed by conductive wiring, a poroussheet of conductive material, and/or other conductive mesheselectrically coupled to electrode 1604. In some implementations, anelectrode 1604 may include electrically coupled scaffolding withinhollow area 2302. The scaffolding may be formed by one or moreconductive beams and/or members placed in and/or across hollow area2302, and/or other scaffolding.

These and/or other features of electrodes 1604 may be configured toincrease a surface area and/or current density of an electrode 1604. Forexample, channels in electrodes 1604 may expose more surface area of anelectrode 1604, and/or create edges and corners that increase currentdensity, without increasing a size (e.g., the diameter) of an electrode1604. The corners, hollow areas, conductive mesh, and/or scaffolding mayfunction in a similar way.

In some implementations, an anti-inflammatory agent may be incorporatedby coating or other means to electrode 1604. For example, a steroidmaterial may be included in hollow area 2302 to reduce the patient'stissue inflammatory response.

FIG. 24 illustrates an embodiment of a lead 2400 with parallel planarsurfaces that include one or more electrodes. This electrical lead (orsimply “lead”) for implantation in a patient is shown as having a distalportion 2402 (e.g., a portion deployed in a patient) and a proximalportion 2404. The distal portion can include one or more electrodes thatare configured to generate therapeutic energy for biological tissue of apatient. The proximal portion can be coupled to the distal portion andconfigured to engage a controller that can be configured to cause theone or more electrodes to generate therapeutic energy.

At least a portion of the lead (e.g., the distal portion) may includetwo parallel planar surfaces that can form a rectangular prism. Variousembodiments of the leads described herein can thus provide a distalportion configured for extravascular implantation. For example, theseplanar surfaces are well-suited for implantation near and/or along apatient's sternum. As used herein, the term “rectangular prism” refersto a lead having rectangular sides and/or cross section. Somesides/cross-sections may be square, as such is a type of rectangle.Also, a “rectangular prism” allows for small deviations from beingperfectly rectangular. For example, edges may be rounded to preventdamage to patient tissues and some rectangular faces may have a slightdegree of curvature (e.g., less than 30°).

The distal portion of the lead may include defibrillation electrodes orcardiac pacing electrodes. In some embodiments, the electrodes on thelead may include both defibrillation electrodes and cardiac pacingelectrodes. One embodiment, depicted in FIG. 24, shows a lead body 2420with a top side 2430, which may include electrodes 2432, 2434, 2436,2438. Also shown as an inset is part of the bottom side 2440 of the lead(which would normally be obscured by the perspective view). The bottomside can have a similar, or identical, set of electrodes (2442, 2444,2446, 2448). In the embodiments described herein, particularly thosereferencing FIGS. 24-27, electrodes are may described with reference toa particular “side” of a lead. However, it is contemplated thatelectrodes can be configured to provide directional stimulation from anyside of the lead body. For example, rather than having electrodespresent on the top side and the bottom side of a directional lead, theremay be electrodes present on a top side and a left side of thedirectional lead. Accordingly, no particular combination, disposition,or shape of the disclosed electrodes should be considered essential tothe present disclosure, other embodiments not specifically described arecontemplated.

As shown in FIG. 24, the electrodes can be thin metallic plates (e.g.,stainless steel, copper, other conductive materials, etc.) of agenerally planar shape. The thin metallic plates can be rectangular (asshown in FIG. 24) but may also be elliptical (as shown in FIG. 25A). Thepanel electrodes may have rounded corners or edges to avoid damagingpatient tissue. Certain embodiments of the thin metallic plates can beon one or both of the two parallel planar surfaces.

The embodiment of FIG. 24 depicts defibrillation panel electrodes alongwith a pacing anode 2450 and pacing cathode 2452. Although theembodiments depicted in the figures include pacing electrodes only onthe bottom of the lead, it is contemplated that the lead mayalternatively include pacing electrodes on either or both sides of thelead. In addition, the location of the anode and cathode may be reversedor moved to different locations on the lead. Additionally, multiplepacing anodes 2450 or pacing cathodes 2452 may be included on the sameside of the lead.

While the embodiment of FIG. 24 depicts four top defibrillationelectrodes and four bottom defibrillation electrodes, it is contemplatedthat various other arrangements and placements may be utilized, forexample, two defibrillation electrodes on top and two defibrillationelectrodes on bottom, etc. Also, it is contemplated that any of thecorresponding top and bottom defibrillation electrodes may be connected,thereby delivering directional electrical energy simultaneously awayfrom the top side and the bottom side of the lead body (e.g., electrodes2432 and 2442 may be connected or formed as a single conductive elementthat extends through the lead body).

FIG. 24 also depicts leads wires (2432 a, 2434 a, 2436 a, 2438 a, 2442a, 2444 a, 2446 a, 2448 a, 2450 a, 2452 a) that extend through or alongthe lead body and connect to their respective electrodes. The expandedtop view illustrates the lead wires (2432 a, 2434 a, 2436 a, 2438 a) forthe electrodes (2432, 2434, 2436, 2438) on the top of the lead. The leadwires can conduct defibrillation and pacing pulses and/or sensingsignals to and/or from a connected pulse generator or computer thatcontrols or processes signals. Similar to other embodiments describedherein, the illustrated defibrillation electrodes can be energized inany combination to provide specific defibrillation vectors fordelivering defibrillation pulses. Such energization can include varyingthe current through the defibrillation electrodes and thereby varyingthe defibrillation energy delivered to the heart. Aspects of suchfunctionality are further described with reference to FIG. 29.Furthermore, multiple or all electrodes may be electrically tiedtogether within the lead body such that only one lead wire emerges atthe distal portion 2404. In some embodiments, the pacing cathode andanode are independently routed to the distal portion of the lead alongwith one defibrillation lead wire that is connected to all of thedefibrillation electrodes. Alternatively, the pacing cathode may beindependent; however, the pacing anode and defibrillation electrodes areelectrically tied together within the lead body. In some instances, thedefibrillation electrodes can act as the pacing anode for cardiacsensing and pacing therapies, while also serving as the defibrillationelectrodes during defibrillation energy delivery. Additionally,redundant wires may be placed to ensure electrical connection with thevarious electrodes in the even that one wire is compromised.

While the depicted components (e.g., directional lead, lead body,electrodes, anode, cathode, etc.) can be designed to various dimensions,in an exemplary implementation, the lead body may have a width ofapproximately 5 mm and a thickness of approximately 2 mm, with panelelectrodes being approximately 20 mm in length by 5 mm in width. Also,the pacing anodes and/or cathodes can have an approximately a 2-5 mmdiameter. As used herein, the term “approximately,” when describingdimensions, means that small deviations are permitted such as typicalmanufacturing tolerances but may also include variations such as within30% of stated dimensions.

The embodiments described herein are not intended to be limited to twoopposite sides of a planar lead body. The teachings can apply similarlyto a lead body that is round, with electrodes located at differentangles around the circumference of the lead body.

FIG. 25A illustrates an embodiment of a lead 2500 with ellipticalelectrodes 2502. Such elliptical electrodes can be similar in manyrespects to the rectangular thin metallic plate electrodes describedabove but can have the benefit of providing a different currentdistribution to the patient than rectangular electrodes.

FIG. 25B illustrates an embodiment similar to the embodiment describedwith reference to FIG. 25A but instead of the electrodes being planar(e.g., a continuous sheet or plate) the defibrillation electrodes may beconstructed as elliptical spiral coils 2520. Such spiral electrodes canhave electrical current passed along the conductor in a spiral pattern.The conductors forming the spiral may have cross-sections that are round(e.g., wire), rectangular (e.g., flat), etc. The dimensions of theoverall spiral can be similar to those described above with regard tothe planar electrodes of FIG. 24. The configuration of the spiral can besuch that there is a sufficient spacing (e.g., approximately 0.05 mm) toallow for flexibility which eases the delivery of the lead as comparedto rigid panels. It is contemplated that the spiral can be constructedsuch that most of the area of the electrode is occupied by conductor,though in some implementations, the central portion may not be fullycovered or may be covered in a looser spiral to manufacturingconstraints. In some embodiments, the surface area of the spiral coilcan be greater than 50%, 60 to 70%, 80 to 90%, or greater than 95% ofthe surface area enclosed by the largest perimeter of the spiral.

As shown in the magnified inset, spiral electrodes may have an innertermination 2522 and an outer termination 2524. The inner and outerterminations can be connected to corresponding connecting lead wires2530 and such lead wires may extend through the lead body similarly tothe configuration described with respect to FIG. 24. Pairs of leads(i.e., a lead for the inner termination and a lead for the outertermination) may be braided to reduce electrical interference. However,in some implementations, there may be a single lead connected to eitherthe inner termination or the outer termination of the spiral. In suchimplementations, only the patient tissue acts as a return for thedelivered current.

FIG. 26 illustrates an embodiment of a lead 2600 that has embeddedelectrodes 2610. Such embedded electrodes 2610 can be similar toprevious embodiments in that they provide directional stimulation. Toprovide this directional stimulation, electrical energy from theembedded electrodes may be partially blocked by the insulating leadbody. As shown in the depicted embodiment, embedded electrodes can bepartially embedded in the portion of the distal portion of the leadhaving the two planar parallel surfaces. In this way, the partiallyembedded electrodes can have an embedded portion and an exposed portion.

In the embodiment of FIG. 26, the embedded electrodes are shown ashelical coils that are oriented in the longitudinal direction (i.e.,along the lengthwise direction of the lead body). The inset of FIG. 26shows a simplified end view of the lead body with a portion of theembedded electrode being outside the lead body and the remainder of theembedded electrode being inside the lead body (as indicated by thedashed lines). As can be seen, the portion of the embedded electrodeoutside the lead body can thus have a similar surface area to thepreviously described planar electrodes. However, due to the helicalshape of the embedded electrode, the portion that is extending from thelead body can have a greater vertical extent (i.e., can bulge outward)as compared to a thin metallic plate electrode and thus increase theavailable surface area.

The electrodes depicted in FIG. 26 are configured such that the exposedportion is on only one of the two planar parallel surfaces. However, itis contemplated that in other embodiments the electrodes may haveportions that extend from more than one face. For example, were theelectrode larger in diameter and/or shifted downward in the inset, therecould be portions extending from both of the two planar parallelsurfaces. In this way, the embedded electrode can provide directionalstimulation, but in multiple directions, similar to embodiments wherethere may be top and bottom electrodes (e.g., in FIG. 24). In someembodiments, the degree of embeddedness can vary. For example, theexposed portion can include at least 25%, 50%, 75%, etc. of thepartially embedded electrode.

As shown, the embedded electrode can be a circular helical coil (i.e.,as if wrapped around a cylindrical object), however, other embodimentscan have the embedded electrode be an elliptical helical coil (i.e., asif the object around which the wire was wrapped had an elliptical ratherthan circular cross-section). Yet other embodiments can have theembedded electrode be a solid electrode having a circular, elliptical,or rectangular cross-section. Some elliptical or rectangular embodimentscan beneficially provide greater surface area while keeping thethickness of the coil (e.g., in the semimajor direction or in a thinnerdirection) at a minimum to reduce the overall thickness of thedirectional lead.

Some embodiments of partially embedded electrodes can include additionalstructural feature(s) to increase surface area beyond that provided bytheir cross-section. Examples of additional structural features caninclude conductive mesh. The conductive mesh may be formed by conductivewiring, a porous sheet of conductive material, and/or other conductivemeshes electrically coupled to partially embedded electrode. Theseand/or other features of partially embedded electrodes may be configuredto increase a surface area and/or current density of an electrode. Forexample, channels in partially embedded electrodes may expose moresurface area, and/or create ridges, edges, and corners that increasecurrent density, without increasing a size (e.g., the diameter) of anelectrode. Implementations having such corners, hollow areas, conductivemesh, and/or scaffolding may function in a similar way.

Other embodiments of the partially embedded electrode can include anadditional structural feature to increase current density beyond thatprovided by its cross-section and may also include a feature to increasecurrent density at particular location(s). For example, as describedabove, ridges, edges, and corners may also have the effect of increasingcurrent density due to charge accumulation. Other embodiments that mayhave increased surface area and/or current density can includeelectrodes with surfaces that have been treated by a sputtering processto create conductive microstructures or coatings that impart a textureto the electrode surface.

FIG. 27 illustrates an embodiment of a lead 2700 including coilelectrodes 2720 that are wrapped around the lead. As shown, theelectrodes can be coils wrapped around a portion of the distal portionof a lead that has two parallel planar surfaces. As used herein, theterm “wrapped” means that the conductor (e.g., wire) is wound in asomewhat helical manner around the lead. The wrapping may havedeviations from being a perfect helix in that the wrapping may be looserin some places and tighter others, for example, to facilitate flexibleportions of the lead or to avoid obstruction or contact of otherelements such as other electrodes. It is contemplated that while mostimplementations involve winding a conductor around the lead, it is alsopossible that equivalent structures can be used such as hollow bands,connected plates, etc. that can provide substantially the samecircumferential coverage.

To provide directional stimulation capability consistent with thepresent disclosure, as shown in FIG. 27, there may be an insulating mask2710 over a portion of the coils(s) on one of the parallel planarsurfaces. Such a mask can be, for example, an electrically insulating orabsorbing material (e.g., rubber, plastic, etc.) to prevent or reducethe transmittal of electrical energy. Such masking can be continuous asshown or can be segmented to only cover one or more individualelectrodes. The masks need not be on the same side of the directionallead. For example, some electrodes may be masked on the top side, andother electrodes may be masked on the bottom side, thereby providingoptions for directional stimulation. Similarly, some implementations canhave masking on multiple sides. For example, masking could be applied tothree of the four sides of the depicted directional lead thus exposingthe portion of the electrode on only one side.

While the embodiments of FIGS. 24-27 depict specific numbers anddisposition of electrodes, it is contemplated that various otherarrangements and dispositions may be utilized, for example, 1, 2, 3, 5,etc. electrodes arranged with varying spaces, etc.

In accordance with certain disclosed embodiments, the present disclosurecontemplates methods that include placing a lead having bothdefibrillation and cardiac pacing electrodes at an extravascularlocation within a patient. The extravascular location can be in amediastinum of the patient, and specifically may be in a region of thecardiac notch or on or near the inner surface of a patient's intercostalmuscle. As such, some placement methods can also include inserting thelead through an intercostal space associated with the cardiac notch ofthe patient.

FIG. 28 depicts an exemplary junction box 2800 that can facilitateconnections between the lead and its control and sensing systems. Suchconnections can be provided to provide pass through between the variouspacing and defibrillation electrodes on the lead and the various inputconnections on the defibrillation source, one example being to animplantable ICD with a DF-4 connector. In the example implementationshown, the previously described leads can have corresponding junctionbox connections (2832 a, 2834 a, 2836 a, 2838 a, 2842 a, 2844 a, 2846 a,2848 a) on the lead side of the junction box. The electrodes can beconnected via a single lead 2810 (e.g., a multi-wire cable) at theconnector cable side of the junction box. There can also be dedicatedconnections 2850 a, 2852 a for a pacing anode and cathode. The junctionbox can also have a lead side connection 2820 to the coil body itself(e.g., to a housing or grounding mesh) and corresponding SVC connection2870. Cathode connection 2852 a can be connected to a corresponding“tip” connection 2840. Anode connection 2850 a can be connected to acorresponding “ring” connection 2860.

An exemplary method utilizing the leads described above is shown in theflowchart of FIG. 29. In implementations where defibrillation electrodesare disposed on different locations of a lead, as described above,defibrillation pulses will propagate in different directions. In suchimplementations, the electrodes can also provide sensing informationallowing determination of which defibrillation electrodes are directedat the heart in a manner to optimize defibrillation. With such adetermination, the defibrillation pulses can be delivered through theoptimal electrodes.

One exemplary method can include, at 2910, receiving sensor data at asensor (e.g., any disclosed electrode or other separate sensor), wherethe sensor data can be representative of electrical signals (e.g., froma heartbeat). At 2920, an algorithm can determine, based on the sensordata, an initial set of electrodes on a defibrillation lead includingmore than two defibrillation electrodes, from which to deliver adefibrillation pulse. The initial electrode set can be one estimated tobe most directed toward the heart and thereby most appropriate fordefibrillation (for example, based on determining relative strengths ofthe signals detected by different sensing electrodes). At 2930, adefibrillation pulse can be delivered with the initial set ofelectrodes. At 2940, post-delivery sensor data can be received, such asby the sensor(s) described above. At 2950, a determination can be made,based at least on the post-delivery sensor data whether thedefibrillation pulse successfully defibrillated the patient. At 2960, ifnecessary, an updated set of electrodes which to deliver a subsequentdefibrillation pulse can be determined, with the process optionallyrepeating starting at 2930 with the delivery of the subsequentdefibrillation pulse.

In step 2950, the determination as to whether defibrillation wassuccessful may include receiving signals representative of the currentheart rhythm and comparing to an expected or desired heart rhythm thatwould be reflective of a successful defibrillation. In step 2960,determining a new set of electrodes may include, for example, switchingto some electrodes on the opposite side of the lead. The determinationmay also result in using a different set of electrodes on the same sideof the lead. In fact, any combination of defibrillation electrodes onthe lead, or in combination with electrodes located off of the lead (forexample, on the housing of an associated pulse generator) may beutilized, including reversing the electrical polarity of thedefibrillation shock. The process of delivering defibrillation energyand selecting different electrode pairings can repeat, cycling throughdifferent combinations, until a successful defibrillation is detected.Again referring to step 2950, once a defibrillation configuration isdetermined that successfully defibrillates the heart, the system canretain that configuration so that it can be used for the firstdefibrillation delivery during a subsequent episode with the patient,thereby increasing the likelihood of successful defibrillation with thefirst delivered shock for future events.

In another lead embodiment, depicted in FIGS. 30A and 30B, an electricallead 3010 may be configured to have its distal portion split apart andtravel in different directions during implantation in a patient. Suchdesigns are referred to herein as “splitting leads.” FIGS. 30A and 30Bdepicts one exemplary embodiment of a splitting lead.

Similar to other leads of the present disclosure, the splitting lead canhave a distal portion 3020 having electrode(s) that are configured togenerate therapeutic energy for biological tissue of the patient. Theelectrodes can include any combination of defibrillation electrodesand/or cardiac pacing electrodes. Also, as partially shown in FIG. 30B,the lead can have a proximal portion 3030 coupled to the distal portionand configured to engage a controller. The controller can be configuredto cause the electrode(s) to generate the therapeutic energy, e.g., viatransmitting current through wires to the various electrodes similar toother disclosed embodiments such as that of FIG. 24.

In the depicted embodiment, the distal portion is configured to splitapart into sub-portions 3040 that travel in multiple directions duringimplantation into the patient. In this example, a delivery system 3000is inserted into a patient (e.g., through an intercostal space in theregion of the cardiac notch) and, after insertion, lead 3010 is advancedand sub-portions 3040 of the lead split off in different directions.While the example of FIGS. 30A and 30B depicts the lead splitting off intwo different directions, the present disclosure contemplates designsfollowing the teachings herein that split off in more directions (e.g.,three directions, four directions, etc.).

The splitting lead designs disclosed herein may be particularly usefulfor ICD/defibrillation applications as they can provide for additionallead length and thus additional area for electrode surface. However, thepresent disclosure contemplates the use of splitting lead designs inpacing applications as well. In some applications, the splitting leaddesigns disclosed herein can include both pacing and defibrillationelectrodes, as taught throughout this disclosure.

FIG. 31A depicts an exemplary placement for a splitting lead 3010 inwhich a lead delivery system (or merely “delivery system”) can beinserted into the patient, for example, through an intercostal spaceassociated with or in the region of the cardiac notch of the patient.Exemplary methods of placing the splitting lead can include operatingthe delivery system to place the distal portion of the lead in anextravascular location of the patient. For example, the extravascularlocation can be in a mediastinum of the patient, in the region of thecardiac notch, and/or on or near the inner surface of an intercostalmuscle. The lead's wires 3120 can extend to a controller 3130, which maybe implanted in the patient.

After insertion, the delivery system 3000 can be operated such that lead3010 can be advanced so that the distal portion of lead 3010 splitsapart into two portions that travel in multiple directions within thepatient. As shown in FIG. 31A, the distal portion of lead 3010 can splitso that sub-portions 3040 travel in opposite directions parallel to asternum of the patient.

FIG. 31B depicts another exemplary placement for a splitting lead 3110where the distal portion of the lead splits apart into two sub-portions3140 that travel in directions approximately 100° apart and under thesternum of the patient. Additional extravascular placements arecontemplated and can include the distal portion of the lead splittinginto more sub-portions (e.g., the distal portion of the lead may splitinto three portions that travel in directions approximately 90° apartand parallel or perpendicular to the sternum of the patient.

FIG. 32 illustrates another view of an exemplary splitting lead, exitingan exemplary delivery system 3000. Such splitting leads can allow forincreased total length and electrode surface area while facilitatingimplantation.

In one embodiment, the distal portion of the lead can be configured tosplit apart into two sub-portions having a combined length ofapproximately 6 cm (e.g., ±up to 1 cm). Numerous other lengths arecontemplated, for example, approximately 4, 5, 7, 10, etc., centimeters.The two sub-portions can be of equal length or may have differentlengths, for example, the distal portion can be configured to splitapart into two sub-portions comprising 60% and 40% respectively of theirtotal combined length. Other implementations can include those withapproximately 55%/45%, 65%/35%, 70%/30%, etc., ratios of lengths and theratios can be determined in order to provide optimal anatomical coveragegiven the implantation location.

Similar to the embodiments described with reference to FIG. 24, thesub-portions can include parallel planar surfaces. Similar to otherembodiments, these sub-portions can then form rectangular prismsincluding the two parallel planar surfaces. As shown in FIG. 32, thedistal portion can be wider (W) than it is thick (T).

During deployment, the lead is advanced through the tip of the deliverysystem (described further below). After placement of the lead in thepatient, the delivery system can then be withdrawn (e.g., as indicatedby the direction of the arrow in FIG. 32). To facilitate withdrawal ofthe delivery system after the lead has been implanted, the proximalportion of the lead can be configured to be thinner than the distalportion of the lead (see, e.g., location 3200 in FIG. 32, identifyingthe location where the proximal portion of the lead thins compared tothe distal portion of the lead). In this manner, the lead can proceeddirectly through the tip of the delivery system 3000.

It is contemplated that each of the split distal portions of thesplitting lead designs disclosed herein may incorporate featuresdescribed above in conjunction with non-splitting lead designs.

For example, the sub-portions can include distal ends 3050 havingflexible portions so as to allow the distal ends to change course whenencountering sufficient resistance traveling through the biologicaltissue of the patient. For example, if the distal ends encounter bone,muscle, etc., the flexible portions can allow the distal ends to stilldeploy within the patient without necessarily affecting or damaging theresisting biological tissue. Such flexible portions can include amaterial that flexes more easily relative to material of other areas ofthe sub-portions. The material can be rubber, soft plastic, etc., whichmay be more flexible than the materials used for the rest of thesub-portions (e.g., metal, hard plastic, etc.). The flexible portionscan include one or more cutouts 3060, which can be one or more areashaving a reduced cross section compared to other areas of thesub-portions. In other embodiments, the flexible portions can beconfigured to cause the distal ends to be biased to change course in aparticular direction. For example, such biasing can include usingflexible materials having different flexibility in different portions,reinforcements such as rods that prevent flexing in certain directions,etc.

The particular shape of the distal ends can vary but, as shown in FIG.32, the distal ends can be at least partially paddle shaped. In otherembodiments, they may be more pointed to have a triangular or wedgeshape or may be more rectangular to form a rectangular prism similar tothe majority of the distal portion as shown.

Some embodiments of splitting leads can implement the use of shapememory material to enable deployment in a particular manner or inparticular directions. For example, the sub-portions can include a shapememory material configured to bend in a predetermined direction when thesub-portions exit the delivery system. In this way, the delivery systemcan contain the sub-portions until they clear the internal structure ofthe delivery system and they will then deploy in their respectivepredetermined directions. Examples of such predetermined directions canresult in creating an acute angle shape between the sub-portions and theproximal portion.

In some embodiments, the sub-portions can be further configured to movein a direction opposite the predetermined direction responsive to theshape memory material being heated to body temperature. For example,some implementations can benefit from having the lead held at a lowertemperature for ease of loading into the delivery system and/ordeployment. Once introduced into the body, after an appropriate lengthof time, the sub-portions would then heat to body temperature and assuch would become deployed in a direction opposite the predetermineddirections (e.g., toward the heart). In some implementations, movementin the direction opposite the predetermined direction can create aninety degree shape, or an obtuse angle shape between the sub-portionsand the proximal portion.

In some embodiments, for example, to assist in deployment through tissuethat may provide resistance, the sub-portions of a splitting lead caninclude distal ends with distal tips 3070 that can be smaller than thedistal ends (e.g., can be pointed or wedged-shaped, or have a ballshape, etc.). Some such implementations can also benefit by havingdistal tips configured to be more rigid compared to other portions ofthe distal end.

FIG. 33 illustrates an embodiment of a splitting lead that includeselectrodes wrapped around the distal portion of the lead. A splittinglead 3010 may, for example, have electrodes 3330 wrapped around thesub-portions 3040 of the lead that travel in multiple directions duringimplantation. In an embodiment where the sub-portions are rectangularprisms, the one or more electrodes wrapped around the sub-portions maybe elliptical in shape. When an electrode is wrapped in such a way, thepresent disclosure refers to its shape as elliptical, even though thewrapped electrode may not be purely oval in shape—since such electrodesare still somewhat oval and are longer in one dimension (e.g., widthdimension of the sub-portion) than in another dimension (e.g., thicknessdimension of the sub-portion). See FIG. 32 for examples of the width Wand thickness T of a sub-portion.

In addition to electrodes being wrapped around the sub-portions 3040,electrode(s) may also be wrapped around a proximal part 3320 of thedistal portion of the lead, specifically, the part of the distal portionthat does not travel in different directions during implantation. Suchwrapped electrodes 3340 can provide additional electrode surface areaand may also be separately energized to deliver therapeutic energy alongadditional vectors. The present disclosure contemplates that suchwrapped electrodes may be utilized for defibrillation and/or pacing.

The exemplary embodiment of FIG. 33 also depicts optional pacingelectrodes 3350 located near the distal ends of the sub-portions. Inother implementations, the pacing electrodes 3350 may not be as close tothe distal ends as they are in FIG. 33 (i.e., they may not be on the“flexible” portions previously-described). In still otherimplementations, the pacing electrodes may be located on only one of thesub-portions, for example, if that particular sub-portion will belocated within the patient at a better location with respect to theheart for pacing.

FIG. 34 illustrates an embodiment of a splitting lead further includinga central pacing electrode 3450 extending between the sub-portions 3040that travel in multiple directions during implantation. This embodimentis similar to other splitting leads described herein and may alsocontain any of the features of such (e.g., wrapped electrodes, pacingelectrodes on sub-portions, etc.). Central pacing electrode 3450 can bedelivered via the delivery system 3000 as part of delivery of thesplitting lead (which may include indentations in its sub-portions 3040so that central pacing electrode 3450 better fits between thesub-portions 3040 when they fold together inside the delivery system).Central pacing electrode 3450 can extend and move along the main axis ofthe delivery system (e.g., straight down into the patient), and may beindependently deployable and retractable/adjustable so the depth of theelectrode tip can be independently set at the time of deployment.Consistent with discussions throughout the present disclosure, centralpacing electrode 3450 may be used in conjunction with other electrodesand can provide additional vectors for the delivery of therapeuticenergy.

FIG. 35 illustrates how this concept of a central pacing electrode 3450can also be implemented with non-splitting lead designs such as thosediscussed above with respect to, for example, FIGS. 18, 19, etc.

FIG. 35 also illustrates how the concept of wrapped electrodes can beimplemented with non-splitting lead designs. Specifically, electrode(s)3520 may be wrapped around a proximal part 3530 of the distal portion ofthe lead, specifically, a part of the distal portion that does nottravel in a different direction during implantation. Such wrappedelectrode(s) 3520 can provide additional electrode surface area and mayalso be separately energized to deliver therapeutic energy alongadditional vectors. The present disclosure contemplates that suchelectrodes may be used for defibrillation and/or pacing.

FIG. 35 also depicts suture holes 3560 that may be located in a proximalpart 3530 of the distal portion of the lead (i.e., the portion that doesnot travel in a different direction during implantation). A physicianmay tie sutures through a patient's tissues and suture holes 3560 inorder to better fix the orientation of the distal portion of the lead atimplantation. The sutures may be tied to intercostal muscle, skin, orany other portion of the patient suitable for securing the lead. Whileone exemplary configuration is depicted in FIG. 35, any number and/orcombination of suture holes and suture hole locations can be included inany of the lead embodiments detailed throughout the present disclosure.For example, such suture holes may be utilized with splitting leads aswell. Furthermore, rather than complete suture holes, one or moregrooves or notches may be located on the proximal part 3530 of thedistal portion of the lead. Such grooves or notches provide indentationsthat may aid in securing of the lead to the patient's tissue.

FIGS. 36 and 37 illustrate embodiments of splitting leads that haveembedded electrodes (see 3630 and 3730 respectively). Suchsplitting-lead embedded electrodes may include the features of any ofthe embedded electrodes previously described with regard to FIG. 26.

The FIGS. 36 and 37 embodiments depict helical coils that are orientedin the longitudinal direction (i.e., along the lengthwise direction ofthe sub-portion). FIG. 36 depicts an embedded electrode 3630 with acircular shaped helical coil (i.e., as if wrapped around a cylindricalobject) while FIG. 37 depicts an embedded electrode 3730 with anelliptical shaped helical coil (i.e., as if wrapped around an objectwith an elliptical cross-section). Other embodiments could have theembedded electrode be a solid electrode having a circular, elliptical(e.g., oval), or rectangular cross-section. Some elliptical orrectangular embodiments can beneficially provide greater surface areawhile keeping the thickness of the coil (e.g., in the semimajordirection or in a thinner direction) at a minimum to reduce the overallthickness of the directional lead.

As shown in the embodiments of FIGS. 36 and 37, the electrodes can bepartially embedded in the sub-portions 3040 that travel in multipledirections during implantation. Similar to earlier embodiments, thesepartially embedded electrodes have an embedded portion 3634/3734 and anexposed portion 3632/3732. In the specific examples of FIGS. 36 and 37,the splitting leads have sub-portions that each comprise two parallelplanar surfaces and the exposed portions of the embedded electrodes areon both of the planar parallel surfaces.

Simplified end views of the splitting lead sub-portions are shown in theinsets of FIGS. 36 and 37, detailing parts of the embedded electrodesthat are exposed, and parts that are embedded. As can be seen, theportion of the embedded electrodes that is exposed can have a similarsurface area to the previously described electrodes. For example, theexposed portions can include at least 25%, 50%, 75%, etc., of thepartially embedded electrode.

These embedded electrodes (also referred to herein equivalently as“partially embedded electrodes”) can include additional structuralfeatures for increasing surface area and/or current density as describedabove with reference to FIG. 26. Also, when referring herein to“embedded” electrodes, it is contemplated that some implementations mayhave a small amount of material between the conductive electrode and thepatient that does not significantly reduce therapeutic energy and thusthe “exposed” portion is still considered exposed. For example, theremay be a thin layer of protective coating or the like between theelectrode and the patient's tissue but this thin layer may cause nosignificant interference with the therapeutic energy provided via theembedded electrode.

FIGS. 38 and 39 illustrate embodiments of embedded electrodes that areexposed only on only one side of the sub-portions. Such embeddedelectrodes will provide more directional stimulation, as discussedabove. In the particular cross-sections of the depicted embodiments, theelectrodes are helical coils and have an exposed portion on only one oftwo planar parallel surfaces.

FIG. 38 also illustrates that there may be multiple embedded electrodes3830 on a single sub-portion 3040. FIG. 38 is similar to FIG. 36 butinstead of one long embedded electrode, there are two shorter embeddedelectrodes that may be generally inline with each other (though someoffset could be present in certain implementations). The embodiment ofFIG. 39 provides an alternative design where two embedded electrodes3930 are positioned side-by-side (e.g., parallel) on the samesub-portion 3040. Such designs can be beneficial in that the splittingof embedded electrodes into sections can provide for a greater number ofvectors or can provide for alternative electrode surface areas andcurrent densities. In other embodiments, there may be any number ofelectrodes besides two (e.g., three, four, five, etc.).

The particular embodiment depicted in FIG. 38 may employ electrodes 3830for defibrillation and electrodes 3850 for pacing, although it iscontemplated that each of the electrodes could be configured to be usedfor pacing and/or defibrillation. While not shown due to the perspectiveview, similar electrodes configurations can be utilized on bothsub-portions. Moreover, other combinations of defibrillation and pacingelectrodes, as discussed throughout this disclosure, may be chosen forthe splitting leads.

FIG. 40A illustrates an embodiment of a lead having offset electrodes4030 and 4032. This embodiment is similar to that shown in FIG. 39 butrather than having two embedded electrodes on each sub-portion 3040there is one embedded electrode on each sub-portion and the exposedportions of the partially embedded electrodes are offset in order toavoid interference (e.g., contact) when the distal portion of theelectrical lead is folded (i.e., before it splits apart intosub-portions that travel in multiple directions during implantation). Asimplified view of a folded lead 4010 is depicted by the insetillustrating how such a lead has a smaller form factor than would bepossible without such an offset. Additionally, as shown in FIG. 40B,sub-portions 3040 may include concavities 4031 and 4033 equally opposingthe shapes of exposed electrodes 4030 and 4032. As shown by the insetsection view, when the distal portion of the lead is folded, the exposedportions of the electrodes fit within the concavities of the opposingsub-portion, thereby creating an even smaller form factor when folded.As with other embodiments, the partially embedded electrodes can includepacing electrodes and/or defibrillation electrodes, as well asoptionally having a pacing electrode extend between the sub-portionsthat travel in multiple directions during implantation.

FIGS. 41A, 41B, and 41C illustrate portions of a delivery systemdeploying a component. The delivery system (for example, the deliverysystem 200 in FIGS. 9A-D or delivery system 3000 in FIG. 30A) caninclude a component advancer configured to advance the component intothe patient. The delivery system can also include a handle configured tobe actuated by an operator. The component advancer can be coupled to thehandle and thereby configured to advance the component into the patientby applying a force to a portion of the component in response toactuation of the handle by the operator. Also, the component advancercan be configured to removably engage a portion of the component todeliver the component into the patient.

As depicted in the delivery system of FIG. 30A, the component can be asplitting lead 3010 having a proximal portion 3030 configured to engagea controller and a distal portion 3020 configured to split apart intosub-portions 3040 that travel in multiple directions during implantationinto a patient. To facilitate the deployment of such a splitting lead,the delivery system can include, as shown in FIG. 41A, an insertion tip4110 having a first ramp 4120 configured to facilitate advancement of afirst sub-portion into the patient in a first direction. There can be asimilar second ramp 4130 (shown in the cross-section view of the tip atthe top of FIG. 41A) configured to facilitate advancement of a secondsub-portion into the patient in a second direction.

As depicted in FIG. 41A, the first direction (i.e., the direction inwhich the first ramp advances the first sub-portion of the lead) can beopposite the second direction (i.e., the direction in which the secondramp advances the second sub-portion of the lead). In other words, thefirst direction can be 180° from the second direction. This directionalsplit is also depicted in FIG. 31A.

In other embodiments, the angle between the first direction and seconddirection can be approximately 100°, allowing for placement of thesub-portions at least partially under the sternum. This directionalsplit is also depicted in FIG. 31B. Other angles between the firstdirection and second direction (and their associated rampconfigurations) are contemplated, for example, 90°, 110°, 120°, etc.

In some implementations, the delivery system can include a third ramp(e.g., in addition to the first and second ramps) configured tofacilitate advancement of a third sub-portion into the patient in athird direction (e.g., 90° from the first and second directions). Thiscan permit deployment of sub-portions approximately 90° apart and eitherparallel or perpendicular to the sternum of the patient.

In other implementations, at least the first ramp, and optionally thesecond ramp, may include a gap 4140 configured to facilitate removal ofthe delivery system after implantation of the splitting lead. An exampleof how gap 4140 can facilitate removal of the delivery system isdepicted in the deployment sequence of FIGS. 41A, 41B, and 41C. Thecomponent (here a splitting lead) is shown in FIG. 41A having thesub-portions of the splitting lead engaging the first ramp and thesecond ramp to split apart in multiple directions. FIG. 41B then depictsa later stage in delivery showing the gap being wide enough to pass theproximal portion 3030 of the splitting lead, but still thinner than thewidth of the sub-portions of the splitting lead, which must engage theramps in order to split off in different directions. Once thesub-portions have split apart such that they no longer engage the ramps,the delivery system can begin to withdraw over the proximal portion ofthe lead. FIG. 41C depicts the delivery system further withdrawn and theproximal portion 3030 of the lead being further exposed.

In another implementation, instead of the first and second ramps beingat the same lengthwise position in the insertion tip (i.e., back, toback) the second ramp may be located at a more distal location than thefirst ramp so that advancement of the second sub-portion will be at alocation deeper into the patient.

In some embodiments, the ramps may additionally include a taper at theirproximal ends to widen the gap in that location. This widening canfacilitate advancement of the component through the insertion tip byreducing the likelihood of the component getting stuck inside the gap.

To facilitate insertion of the delivery tool into patient tissue, theinsertion tip may include a tissue-separating component 4150. As shownin FIGS. 41A, 41B, and 41C, the tissue-separating component can bewedge-shaped to separate and/or cut through tissue as needed forinsertion. The tissue-separating component may also have a blunteddistal end to reduce or avoid damage to tissue, blood vessels, etc. Inthe same manner as discussed above with regard to the ramps, thetissue-spreading component can include a gap configured to facilitateremoval of the delivery system after implantation of the splitting lead.

Some embodiments of the insertion tip can include a movable coverconfigured to cover the gap during implantation. The movable cover canbe configured to prevent tissue from accumulating in the gap when theinsertion tip is pushed through patient tissue. Such movable covers caninclude, for example, a cover that can be pulled off when properinsertion depth is reached. In other examples, the cover can include apivot, hinge, or flap to allow the movable cover to swivel out of theway of the component.

As depicted in FIG. 41D, other embodiments may incorporate a gap-fillingcomponent 4040 on the distal end of the splitting lead to fill the gapbetween the tissue-separating components. Gap-filling components 4040may be incorporated on the distal ends of sub-portions 3040 such that,when the splitting lead is folded and loaded into the delivery system,the gap-filling components fit within and fill the gap of thetissue-separating component. Once inserted within the patient tissue,the gap-filling components are deployed with sub-sections 3040, asdescribed previously with regard to FIG. 41A, thereby clearing the gapand allowing for proximal portion 3030 to travel through the gap, asshown in FIGS. 41B and 41C.

As described above, in some implementations, system 200 (FIG. 3)includes the electrical lead 1600 (FIG. 16), handle 300 (FIG. 3),component advancer 302 (FIG. 3), first and second insertion tips 304,306 (FIG. 3), and/or other components. First insertion tip 304 andsecond insertion tip 306 may be configured to close around a distal tipof the electrical lead when the electrical lead is placed withincomponent advancer 302. First insertion tip 304 and second insertion tip306 may be configured to push through biological tissue when in a closedposition and to open to enable the electrical lead to exit fromcomponent advancer 302 into the patient. Component advancer 302, firstinsertion tip 304, and second insertion tip 306 may be configured tomaintain the electrical lead in a particular orientation during the exitof the component from component advancer 302 into the patient. Also asdescribed above, first insertion tip 304 may include a ramped portionconfigured to facilitate advancement of the component into the patientin a particular direction, and/or the electrical lead may be configuredto bend in a predetermined direction after the exit of the componentfrom the component advancer (e.g., because of its shape memoryproperties, etc.).

FIG. 42 illustrates components of delivery system 200 configured to load(or reload) a component (e.g., an electrical lead 1600 shown in FIG. 16)into delivery system 200. In some implementations, to facilitatereloading delivery system 200, an operator may thread proximal portion1606 (FIG. 16) of lead 1600 backwards through insertion tips 304, 306(FIG. 3), through pusher tube 1300 (in an implementation shown in FIG.13) and out through an opening 4230 in handle 300. In someimplementations, component advancer 302 may be configured to reload acomponent (e.g., an electrical lead) into delivery system 200. In suchimplementations, handle 300 may be configured to move from an advancedposition 4200 to a retracted position 4202 to facilitate the reload ofthe component (e.g., the electrical lead).

In some implementations, handle 300 may include a dock 4204 configuredto engage an alignment block coupled with the component (e.g.,electrical lead) such that, responsive to handle 300 moving fromadvanced position 4200 to retracted position 4202, the engagementbetween dock 4204 and the alignment block draws the component intodelivery system 200 to reload delivery system 200. As a non-limitingexample using the implementation of component advancer 302 shown in FIG.13-14, once the alignment block and electrical lead are properly seatedwithin dock 4204, handle 300 may be re-cocked (e.g., moved from position4200 to position 4202), which draws distal portion 1602 of electricallead 1600 into delivery system 200 and closes insertion tips 304, 306(FIG. 3).

In some implementations, dock 4204 may comprise one or more alignmentand/or locking protrusions 4206 (the example in FIG. 42 illustrates twoprotrusions 4206) located on a portion 4208 of handle 300 towardcomponent advancer 302. Locking protrusions 4206 may have a “U” shapedchannel configured to receive a wire portion (e.g., part of proximalportion 1606) of an electrical lead 1600 (FIG. 16). Locking protrusions4206 may have a spacing 4210 that corresponds to a size of an alignmentblock on the wire portion of electrical lead 1600 and allows thealignment block to fit between locking protrusions 4206 (with the wireportions resting in the “U” shaped channels of locking protrusions4206).

FIG. 43 illustrates an example of an alignment block 4300 coupled toproximal portion 1606 of an electrical lead 1600. Alignment block 4300may have a cylindrical shape, for example, with a length matchingspacing 4210 configured to fit between locking protrusions 4206 shown inFIG. 42.

Returning to FIG. 42, in some implementations, handle 300 may include analignment surface 4220 configured to receive the proximal portion 1606(FIG. 43) of electrical lead 1600 (FIG. 16) such that, responsive tohandle 300 moving from the advanced position to the retracted position,the component is drawn into delivery system 200 to reload deliverysystem 200. In some implementations, alignment surface 4220 may be thesame as surface 4208, but without locking protrusions 4206. In someimplementations, an operator may hold proximal portion 1606 againstalignment surface 4220, within a retention block 4206, with fingerpressure while handle 300 moves from advanced position 4200 to retractedposition 4202, for example. In some implementations, the alignment block4300 may not be utilized.

In the following, further features, characteristics, and exemplarytechnical solutions of the present disclosure will be described in termsof items that may be optionally claimed in any combination:

Item 1: An electrical lead for implantation in a patient, the leadcomprising: a distal portion comprising one or more electrodes that areconfigured to generate therapeutic energy for biological tissue of thepatient; and a proximal portion coupled to the distal portion andconfigured to engage a controller, the controller configured to causethe one or more electrodes to generate the therapeutic energy, whereinat least a portion of the distal portion of the lead comprises twoparallel planar surfaces that include the one or more electrodes.

Item 2: The electrical lead of Item 1, wherein the two parallel planarsurfaces comprise a rectangular prism and the one or more electrodescomprise defibrillation electrodes or cardiac pacing electrodes.

Item 3: The electrical lead of any one of the preceding Items, whereinthe one or more electrodes comprise both defibrillation electrodes andcardiac pacing electrodes.

Item 4: The electrical lead of any one of the preceding Items, whereinthe distal portion is configured for extravascular implantation andwherein the one or more electrodes comprise both defibrillationelectrodes and cardiac pacing electrodes.

Item 5: The electrical lead of any one of the preceding Items, whereinone or more electrodes comprise thin metallic plates.

Item 6: The electrical lead of any one of the preceding Items, whereinthe thin metallic plates are rectangular.

Item 7: The electrical lead of any one of the preceding Items, whereinthe thin metallic plates are elliptical.

Item 8: The electrical lead of any one of the preceding Items, whereinthe thin metallic plates are on both of the two parallel planarsurfaces.

Item 9: The electrical lead of any one of the preceding Items, whereinone or more electrodes comprise coil(s) wrapped around the portion ofthe distal portion of the lead comprising two parallel planar surfaces.

Item 10: The electrical lead of any one of the preceding Items, furthercomprising an electrically insulating mask over a portion of the coil(s)on one of the parallel planar surfaces.

Item 11: The electrical lead of any one of the preceding Items, whereinat least one electrode is partially embedded in the portion of thedistal portion of the lead comprising two planar parallel surfaces, andthe partially embedded electrode has an embedded portion and an exposedportion.

Item 12: The electrical lead of any one of the preceding Items, whereinthe exposed portion is on both of the two planar parallel surfaces.

Item 13: The electrical lead of any one of the preceding Items, whereinthe exposed portion is on only one of the two planar parallel surfaces.

Item 14: The electrical lead of any one of the preceding Items, whereinthe exposed portion comprises at least 50% of a perimeter of thepartially embedded electrode.

Item 15: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrode is a circular helical coil.

Item 16: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrode is an elliptical helical coil.

Item 17: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrode is a solid electrode having a circular,elliptical, or rectangular cross section.

Item 18: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrode includes an additional structuralfeature to increase surface area beyond that provided by itscross-section.

Item 19: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrode includes an additional structuralfeature to increase current density beyond that provided by itscross-section.

Item 20: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrode comprises a feature to increase currentdensity at particular location(s).

Item 21: A method comprising: placing a lead comprising bothdefibrillation and cardiac pacing electrodes at an extravascularlocation within a patient.

Item 22: The method of any one of the preceding Items, wherein theextravascular location is in a mediastinum of the patient.

Item 23: The method of any one of the preceding Items, wherein theextravascular location is in a region of a cardiac notch.

Item 24: The method of any one of the preceding Items, wherein theextravascular location is on or near the inner surface of an intercostalmuscle.

Item 25: The method of any one of the preceding Items, wherein theplacing further comprises inserting the lead through an intercostalspace associated with the cardiac notch of a patient.

Item 26: A computer program product comprising a non-transitory,machine-readable medium storing instructions which, when executed by atleast one programmable processor, cause the at least one programmableprocessor to perform operations comprising: receiving sensor data;determining, based at least on the sensor data, an initial set ofelectrodes on a defibrillation lead including more than twodefibrillation electrodes, from which to deliver a defibrillation pulse;delivering the defibrillation pulse with the initial set of electrodes;receiving post-delivery sensor data; determining, based at least on thepost-delivery sensor data whether the defibrillation pulse successfullydefibrillated the patient; and if necessary, determining an updated setof electrodes from which to deliver a subsequent defibrillation pulse.

Item 27: An electrical lead for implantation in a patient, the leadcomprising: a distal portion comprising one or more electrodes that areconfigured to generate therapeutic energy for biological tissue of thepatient; and a proximal portion coupled to the distal portion andconfigured to engage a controller, the controller configured to causethe one or more electrodes to generate the therapeutic energy, whereinthe distal portion is configured to split apart into sub-portions thattravel in multiple directions during implantation into the patient.

Item 28: The electrical lead of any one of the preceding Items, whereinthe one or more electrodes comprise defibrillation electrodes and/orcardiac pacing electrodes.

Item 29: The electrical lead of any one of the preceding Items, whereinthe distal portion is configured to split apart into two sub-portionshaving a combined length of approximately 6 cm.

Item 30: The electrical lead of any one of the preceding Items, whereinthe distal portion is configured to split apart into two sub-portions ofequal length.

Item 31: The electrical lead of any one of the preceding Items, whereinthe distal portion is configured to split apart into two sub-portionshaving different lengths.

Item 32: The electrical lead of any one of the preceding Items, whereinthe distal portion is configured to split apart into two sub-portionscomprising 60% and 40% respectively of their total combined length.

Item 33: The electrical lead of any one of the preceding Items, whereinthe sub-portions comprise parallel planar surfaces.

Item 34: The electrical lead of any one of the preceding Items, whereinthe sub-portions comprise rectangular prisms including two parallelplanar surfaces.

Item 35: The electrical lead of any one of the preceding Items, whereinthe distal portion is wider than it is thick and the proximal portion isconfigured to be thinner than the distal portion in a manner thatfacilitates removal from a delivery system.

Item 36: The electrical lead of any one of the preceding Items, whereinthe sub-portions include distal ends and the distal ends includeflexible portions so as to allow the distal ends to change course whenencountering sufficient resistance traveling through the biologicaltissue of the patient.

Item 37: The electrical lead of any one of the preceding Items, whereinthe flexible portions comprise a material that flexes more easilyrelative to material of other areas of the sub-portions.

Item 38: The electrical lead of any one of the preceding Items, whereinthe flexible portions comprise one or more cutouts, the one or morecutouts comprising one or more areas having a reduced cross sectioncompared to other areas of the sub-portions.

Item 39: The electrical lead of any one of the preceding Items, whereinthe flexible portions are configured to cause the distal ends to bebiased to change course in a particular direction.

Item 40: The electrical lead of any one of the preceding Items, whereinthe distal ends are at least partially paddle shaped.

Item 41: The electrical lead of any one of the preceding Items, whereinthe sub-portions comprise a shape memory material configured to bend ina predetermined direction when the sub-portions exit a delivery system.

Item 42: The electrical lead of any one of the preceding Items, whereinthe sub-portions are further configured to move in a direction oppositethe predetermined direction responsive to the shape memory materialbeing heated to body temperature.

Item 43: The electrical lead of any one of the preceding Items, whereinthe predetermined direction creates an acute angle shape between thesub-portions and the proximal portion.

Item 44: The electrical lead of any one of the preceding Items, whereinthe movement in the direction opposite the predetermined directioncreates a ninety degree shape, or an obtuse angle shape between thesub-portions and the proximal portion.

Item 45: The electrical lead of any one of the preceding Items, whereinthe sub-portions include distal ends and the distal ends include distaltips that are smaller than the distal ends.

Item 46: The electrical lead of any one of the preceding Items, whereinthe sub-portions include distal ends and the distal ends include distaltips that are more rigid compared to other portions of the distal end.

Item 47: The electrical lead of any one of the preceding Items, whereinelectrodes are wrapped around the sub-portions that travel in multipledirections during implantation.

Item 48: The electrical lead of any one of the preceding Items, whereinthe sub-portions comprise rectangular prisms including two parallelplanar surfaces.

Item 49: The electrical lead of any one of the preceding Items, whereinthe one or more electrodes wrapped around the sub-portions areelliptical.

Item 50: The electrical lead of any one of the preceding Items, whereinelectrode(s) are also wrapped around a proximal part of the distalportion of the lead, which does not travel in a different directionduring implantation.

Item 51: The electrical lead of any one of the preceding Items, whereinthe electrodes wrapped around the distal portion of the lead comprisepacing electrodes.

Item 52: The electrical lead of any one of the preceding Items, whereinthe electrodes wrapped around the distal portion of the lead comprisedefibrillation electrodes.

Item 53: The electrical lead of any one of the preceding Items, furthercomprising pacing electrodes.

Item 54: The electrical lead of any one of the preceding Items, whereinthe pacing electrodes are located near distal ends of the sub-portions.

Item 55: The electrical lead of any one of the preceding Items, whereinthe pacing electrodes are located on only one of the sub-portions.

Item 56: The electrical lead of any one of the preceding Items, whereina pacing electrode extends between the sub-portions that travel inmultiple directions during implantation.

Item 57: The electrical lead of any one of the preceding Items, whereinelectrodes are partially embedded in the sub-portions that travel inmultiple directions during implantation, and the partially embeddedelectrodes have an embedded portion and an exposed portion.

Item 58: The electrical lead of any one of the preceding Items, whereinthe sub-portions each comprise two parallel planar surfaces and theexposed portion is on both of the planar parallel surfaces.

Item 59: The electrical lead of any one of the preceding Items, whereinthe sub-portions each comprise two parallel planar surfaces and theexposed portion is on only one of the two planar parallel surfaces.

Item 60: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrodes are helical coils.

Item 61: The electrical lead of any one of the preceding Items, whereinthe exposed portions of the partially embedded electrodes are offset inorder to avoid interference when the distal portion of the electricallead is folded before it splits apart into sub-portions that travel inmultiple directions during implantation.

Item 62: The electrical lead of any one of the preceding Items, furthercomprising concavities on the sub-portions such that exposed portions ofthe offset electrodes fit within the concavities when the electricallead is folded.

Item 63: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrodes comprise pacing electrodes.

Item 64: The electrical lead of any one of the preceding Items, whereinthe partially embedded electrodes comprise defibrillation electrodes.

Item 65: The electrical lead of any one of the preceding Items, furthercomprising pacing electrodes.

Item 66: The electrical lead of any one of the preceding Items, whereina central pacing electrode extends between the sub-portions that travelin multiple directions during implantation.

Item 67: The electrical lead of any one of the preceding Items, furthercomprising one or more suture holes in a proximal part of the distalportion of the lead, which does not travel in a different directionduring implantation.

Item 68: The electrical lead of any one of the preceding Items, furthercomprising one or more grooves or notches on a proximal part of thedistal portion of the lead, which does not travel in a differentdirection during implantation.

Item 69: A delivery system for a component that is a splitting leadhaving a proximal portion configured to engage a controller and a distalportion configured to split apart into sub-portions that travel inmultiple directions during implantation into a patient, the deliverysystem comprising: a handle configured to be actuated by an operator; acomponent advancer configured to advance the component into the patient,the component advancer configured to removably engage a portion of thecomponent, the component advancer coupled to the handle and configuredto advance the component into the patient by applying a force to theportion of the component in response to actuation of the handle by theoperator; and an insertion tip comprising: a first ramp configured tofacilitate advancement of a first sub-portion into the patient in afirst direction; and a second ramp configured to facilitate advancementof a second sub-portion into the patient in a second direction.

Item 70: The delivery system of any one of the preceding Items, whereinfirst direction is opposite the second direction.

Item 71: The delivery system of any one of the preceding Items, whereinan angle between the first direction and second direction isapproximately 100°.

Item 72: The delivery system of any one of the preceding Items, furthercomprising a third ramp configured to facilitate advancement of a thirdsub-portion into the patient in a third direction.

Item 73: The delivery system of any one of the preceding Items, whereinat least the first ramp includes a gap configured to facilitate removalof the delivery system after implantation of the splitting lead.

Item 74: The delivery system of any one of the preceding Items, whereinthe gap is wide enough to pass the proximal portion of the splittinglead but also thinner than a width of the sub-portions of the splittinglead so that the sub-portions of the splitting lead engage the firstramp and the second ramp to split apart in multiple directions.

Item 75: The delivery system of any one of the preceding Items, whereinthe second ramp is at a more distal location than the first ramp so thatadvancement of the second sub-portion will be at a location deeper intothe patient.

Item 76: The delivery system of any one of the preceding Items, whereinthe insertion tip further comprises a tissue-separating component.

Item 77: The delivery system of any one of the preceding Items, whereinthe tissue-separating component is wedge-shaped.

Item 78: The delivery system of any one of the preceding Items, whereinthe tissue-separating component has a blunted distal end.

Item 79: The delivery system of any one of the preceding Items, whereinthe tissue-separating component includes a gap configured to facilitateremoval of the delivery system after implantation of the splitting lead.

Item 80: The delivery system of any one of the preceding Items, whereinthe insertion tip further includes a movable cover configured to coverthe gap.

Item 81: The delivery system of any one of the preceding Items, furthercomprising the splitting lead, wherein a distal end of the splittinglead includes a gap-filling component configured to fill the gap of thetissue-separating component when the splitting lead is loaded into thedelivery system.

Item 82: A method comprising: inserting a lead delivery system into apatient; operating the lead delivery system to advance a lead so that adistal portion of the lead splits apart and travels in multipledirections within the patient.

Item 83: The method any one of the preceding Items, wherein insertingthe lead delivery system comprises insertion through an intercostalspace associated with the cardiac notch of a patient.

Item 84: The method of any one of the preceding Items, furthercomprising operating the lead delivery system to place the distalportion of the lead in an extravascular location of the patient.

Item 85: The method of any one of the preceding Items, wherein theextravascular location is in a mediastinum of the patient.

Item 86: The method of any one of the preceding Items, wherein theextravascular location is in a region of a cardiac notch.

Item 87: The method of any one of the preceding Items, wherein theextravascular location is on or near the inner surface of an intercostalmuscle.

Item 88: The method of any one of the preceding Items, wherein thedistal portion of the lead splits apart into two portions that travel inopposite directions parallel to a sternum of the patient.

Item 89: The method of any one of the preceding Items, wherein thedistal portion of the lead splits apart into two portions that travel indirections approximately 100° apart and under a sternum of the patient.

Item 90: The method of any one of the preceding Items, wherein thedistal portion of the lead splits apart into three portions that travelin directions approximately 90° apart and parallel or perpendicular to asternum of the patient.

One or more aspects or features of the subject matter described hereincan be realized in digital electronic circuitry, integrated circuitry,specially designed application specific integrated circuits (ASICs),field programmable gate arrays (FPGAs) computer hardware, firmware,software, and/or combinations thereof. These various aspects or featurescan include implementation in one or more computer programs that areexecutable and/or interpretable on a programmable system including atleast one programmable processor, which can be special or generalpurpose, coupled to receive data and instructions from, and to transmitdata and instructions to, a storage system, at least one input device,and at least one output device. The programmable system or computingsystem may include clients and servers. A client and server aregenerally remote from each other and typically interact through acommunication network. The relationship of client and server arises byvirtue of computer programs running on the respective computers andhaving a client-server relationship to each other.

These computer programs, which can also be referred to programs,software, software applications, applications, components, or code,include machine instructions for a programmable processor, and can beimplemented in a high-level procedural language, an object-orientedprogramming language, a functional programming language, a logicalprogramming language, and/or in assembly/machine language. As usedherein, the term “machine-readable medium” (or “computer readablemedium”) refers to any computer program product, apparatus and/ordevice, such as for example magnetic discs, optical disks, memory, andProgrammable Logic Devices (PLDs), used to provide machine instructionsand/or data to a programmable processor, including a machine-readablemedium that receives machine instructions as a machine-readable signal.The term “machine-readable signal” (or “computer readable signal”)refers to any signal used to provide machine instructions and/or data toa programmable processor. The machine-readable medium can store suchmachine instructions non-transitorily, such as for example as would anon-transient solid-state memory or a magnetic hard drive or anyequivalent storage medium. The machine-readable medium can alternativelyor additionally store such machine instructions in a transient manner,such as for example as would a processor cache or other random accessmemory associated with one or more physical processor cores.

To provide for interaction with a user, one or more aspects or featuresof the subject matter described herein can be implemented on a computerhaving a display device, such as for example a cathode ray tube (CRT) ora liquid crystal display (LCD) or a light emitting diode (LED) monitorfor displaying information to the user and a keyboard and a pointingdevice, such as for example a mouse or a trackball, by which the usermay provide input to the computer. Other kinds of devices can be used toprovide for interaction with a user as well. For example, feedbackprovided to the user can be any form of sensory feedback, such as forexample visual feedback, auditory feedback, or tactile feedback; andinput from the user may be received in any form, including, but notlimited to, acoustic, speech, or tactile input. Other possible inputdevices include, but are not limited to, touch screens or othertouch-sensitive devices such as single or multi-point resistive orcapacitive trackpads, voice recognition hardware and software, opticalscanners, optical pointers, digital image capture devices and associatedinterpretation software, and the like.

In the descriptions above and in the claims, phrases such as “at leastone of” or “one or more of” may occur followed by a conjunctive list ofelements or features. The term “and/or” may also occur in a list of twoor more elements or features. Unless otherwise implicitly or explicitlycontradicted by the context in which it used, such a phrase is intendedto mean any of the listed elements or features individually or any ofthe recited elements or features in combination with any of the otherrecited elements or features. For example, the phrases “at least one ofA and B;” “one or more of A and B;” and “A and/or B” are each intendedto mean “A alone, B alone, or A and B together. ” A similarinterpretation is also intended for lists including three or more items.For example, the phrases “at least one of A, B, and C;” “one or more ofA, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, Balone, C alone, A and B together, A and C together, B and C together, orA and B and C together. ” Use of the term “based on,” above and in theclaims is intended to mean, “based at least in part on,” such that anunrecited feature or element is also permissible.

The subject matter described herein can be embodied in systems,apparatus, methods, computer programs and/or articles depending on thedesired configuration. Any methods or the logic flows depicted in theaccompanying figures and/or described herein do not necessarily requirethe particular order shown, or sequential order, to achieve desirableresults. The implementations set forth in the foregoing description donot represent all implementations consistent with the subject matterdescribed herein. Instead, they are merely some examples consistent withaspects related to the described subject matter. Although a fewvariations have been described in detail above, other modifications oradditions are possible. In particular, further features and/orvariations can be provided in addition to those set forth herein. Theimplementations described above can be directed to various combinationsand subcombinations of the disclosed features and/or combinations andsubcombinations of further features noted above. Furthermore, abovedescribed advantages are not intended to limit the application of anyissued claims to processes and structures accomplishing any or all ofthe advantages.

Additionally, section headings shall not limit or characterize theinvention(s) set out in any claims that may issue from this disclosure.Further, the description of a technology in the “Background” is not tobe construed as an admission that technology is prior art to anyinvention(s) in this disclosure. Neither is the “Summary” to beconsidered as a characterization of the invention(s) set forth in issuedclaims. Furthermore, any reference to this disclosure in general or useof the word “invention” in the singular is not intended to imply anylimitation on the scope of the claims set forth below. Multipleinventions may be set forth according to the limitations of the multipleclaims issuing from this disclosure, and such claims accordingly definethe invention(s), and their equivalents, that are protected thereby.

1-26. (canceled)
 27. An electrical lead for implantation in a patient,the lead comprising: a distal portion comprising one or more electrodesthat are configured to generate therapeutic energy for biological tissueof the patient; and a proximal portion coupled to the distal portion andconfigured to engage a controller, the controller configured to causethe one or more electrodes to generate the therapeutic energy, whereinthe distal portion is configured to split apart into sub-portions thattravel in multiple directions during implantation into the patient. 28.The electrical lead of claim 27, wherein the one or more electrodescomprise defibrillation electrodes and/or cardiac pacing electrodes. 29.The electrical lead of claim 27, wherein the distal portion isconfigured to split apart into two sub-portions having a combined lengthof approximately 6 cm.
 30. (canceled)
 31. (canceled)
 32. (canceled) 33.(canceled)
 34. (canceled)
 35. The electrical lead of claim 27, whereinthe distal portion is wider than it is thick and the proximal portion isconfigured to be thinner than the distal portion in a manner thatfacilitates removal from a delivery system.
 36. The electrical lead ofclaim 27, wherein the sub-portions include distal ends and the distalends include flexible portions so as to allow the distal ends to changecourse when encountering sufficient resistance traveling through thebiological tissue of the patient.
 37. (canceled)
 38. (canceled)
 39. Theelectrical lead of claim 36, wherein the flexible portions areconfigured to cause the distal ends to be biased to change course in aparticular direction.
 40. (canceled)
 41. The electrical lead of claim27, wherein the sub-portions comprise a shape memory material configuredto bend in a predetermined direction when the sub-portions exit adelivery system.
 42. The electrical lead of claim 41, wherein thesub-portions are further configured to move in a direction opposite thepredetermined direction responsive to the shape memory material beingheated to body temperature.
 43. The electrical lead of claim 41, whereinthe predetermined direction creates an acute angle shape between thesub-portions and the proximal portion.
 44. (canceled)
 45. (canceled) 46.(canceled)
 47. The electrical lead of claim 27, wherein electrodes arewrapped around the sub-portions that travel in multiple directionsduring implantation.
 48. The electrical lead of claim 47, wherein thesub-portions comprise rectangular prisms including two parallel planarsurfaces.
 49. (canceled)
 50. The electrical lead of claim 47, whereinelectrode(s) are also wrapped around a proximal part of the distalportion of the lead, which does not travel in a different directionduring implantation.
 51. The electrical lead of claim 50, wherein theelectrodes wrapped around the distal portion of the lead comprise pacingelectrodes.
 52. The electrical lead of claim 50, wherein the electrodeswrapped around the distal portion of the lead comprise defibrillationelectrodes.
 53. (canceled)
 54. (canceled)
 55. (canceled)
 56. Theelectrical lead of claim 27, wherein a central pacing electrode extendsbetween the sub-portions that travel in multiple directions duringimplantation.
 57. The electrical lead of claim 27, wherein electrodesare partially embedded in the sub-portions that travel in multipledirections during implantation, and the partially embedded electrodeshave an embedded portion and an exposed portion.
 58. (canceled) 59.(canceled)
 60. (canceled)
 61. The electrical lead of claim 57, whereinthe exposed portions of the partially embedded electrodes are offset inorder to avoid interference when the distal portion of the electricallead is folded before it splits apart into sub-portions that travel inmultiple directions during implantation.
 62. The electrical lead ofclaim 61, further comprising concavities on the sub-portions such thatexposed portions of the offset electrodes fit within the concavitieswhen the electrical lead is folded.
 63. The electrical lead of claim 57,wherein the partially embedded electrodes comprise pacing electrodes.64. The electrical lead of claim 57, wherein the partially embeddedelectrodes comprise defibrillation electrodes.
 65. (canceled)
 66. Theelectrical lead of claim 57, wherein a central pacing electrode extendsbetween the sub-portions that travel in multiple directions duringimplantation.
 67. The electrical lead of claim 27, further comprisingone or more suture holes in a proximal part of the distal portion of thelead, which does not travel in a different direction duringimplantation.
 68. The electrical lead of claim 27, further comprisingone or more grooves or notches on a proximal part of the distal portionof the lead, which does not travel in a different direction duringimplantation.
 69. A delivery system for a component that is a splittinglead having a proximal portion configured to engage a controller and adistal portion configured to split apart into sub-portions that travelin multiple directions during implantation into a patient, the deliverysystem comprising: a handle configured to be actuated by an operator; acomponent advancer configured to advance the component into the patient,the component advancer configured to removably engage a portion of thecomponent, the component advancer coupled to the handle and configuredto advance the component into the patient by applying a force to theportion of the component in response to actuation of the handle by theoperator; and an insertion tip comprising: a first ramp configured tofacilitate advancement of a first sub-portion into the patient in afirst direction; and a second ramp configured to facilitate advancementof a second sub-portion into the patient in a second direction.
 70. Thedelivery system of claim 69, wherein first direction is opposite thesecond direction.
 71. (canceled)
 72. (canceled)
 73. The delivery systemof claim 69, wherein at least the first ramp includes a gap configuredto facilitate removal of the delivery system after implantation of thesplitting lead.
 74. The delivery system of claim 73, wherein the gap iswide enough to pass the proximal portion of the splitting lead but alsothinner than a width of the sub-portions of the splitting lead so thatthe sub-portions of the splitting lead engage the first ramp and thesecond ramp to split apart in multiple directions.
 75. (canceled) 76.The delivery system of claim 69, wherein the insertion tip furthercomprises a tissue-separating component.
 77. (canceled)
 78. (canceled)79. The delivery system of claim 76, wherein the tissue-separatingcomponent includes a gap configured to facilitate removal of thedelivery system after implantation of the splitting lead.
 80. Thedelivery system of claim 79, wherein the insertion tip further includesa movable cover configured to cover the gap.
 81. The delivery system ofclaim 79, further comprising the splitting lead, wherein a distal end ofthe splitting lead includes a gap-filling component configured to fillthe gap of the tissue-separating component when the splitting lead isloaded into the delivery system.
 82. A method comprising: inserting alead delivery system into a patient; operating the lead delivery systemto advance a lead so that a distal portion of the lead splits apart andtravels in multiple directions within the patient.
 83. The method ofclaim 82, wherein inserting the lead delivery system comprises insertionthrough an intercostal space associated with the cardiac notch of apatient.
 84. The method of claim 82 further comprising operating thelead delivery system to place the distal portion of the lead in anextravascular location of the patient.
 85. The method of claim 84,wherein the extravascular location is in a mediastinum of the patient.86. The method of claim 85, wherein the extravascular location is in aregion of a cardiac notch.
 87. The method of claim 85, wherein theextravascular location is on or near the inner surface of an intercostalmuscle.
 88. (canceled)
 89. (canceled)
 90. (canceled)